Masked intraocular implants and lenses

ABSTRACT

Intraocular implants and methods of making intraocular implants are provided. The intraocular implants can improve the vision of a patient, such as by increasing the depth of focus of an eye of a patient. In particular, the intraocular implants can include a mask having an annular portion with a relatively low visible light transmission surrounding a relatively high transmission central portion such as a clear lens or aperture. This construct is adapted to provide an annular mask with a small aperture for light to pass through to the retina to increase depth of focus. The intraocular implant may have an optical power for refractive correction. The intraocular implant may be implanted in any location along the optical pathway in the eye, e.g., as an implant in the anterior or posterior chamber.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/856,492, filed Aug. 13, 2010, entitled “MASKED INTRAOCULAR IMPLANTSAND LENSES,” now pending, which claims the benefit of U.S. ProvisionalApplication Nos. 61/233,794, filed Aug. 13, 2009, and 61/233,804, filedAug. 13, 2009, the entirety of each of which is hereby incorporated byreference.

BACKGROUND

1. Field

This application relates generally to the field of intraocular devices.More particularly, this application is directed to intraocular implantsand lenses (IOLs), with an aperture to increase depth of focus (e.g.“masked” intraocular lenses) and methods of making.

2. Description of the Related Art

The human eye functions to provide vision by transmitting and focusinglight through a clear outer portion called the cornea, and furtherrefining the focus of the image by way of a crystalline lens onto aretina. The quality of the focused image depends on many factorsincluding the size and shape of the eye, and the transparency of thecornea and the lens.

The optical power of the eye is determined by the optical power of thecornea and the crystalline lens. In a normal, healthy eye, sharp imagesof distant objects are formed on the retina (emmetropia). In many eyes,images of distant objects are either formed in front of the retinabecause the eye is abnormally long or the cornea is abnormally steep(myopia), or formed in back of the retina because the eye is abnormallyshort or the cornea is abnormally flat (hyperopia). The cornea also maybe asymmetric or toric, resulting in an uncompensated cylindricalrefractive error referred to as corneal astigmatism.

A normally functioning human eye is capable of selectively focusing oneither near or far objects through a process known as accommodation.Accommodation is achieved by inducing deformation in a lens locatedinside the eye, which is referred to as the crystalline lens. Suchdeformation is induced by muscles called ciliary muscles. In mostindividuals, the ability to accommodate diminishes with age and theseindividuals cannot see up close without vision correction. If far visionalso is deficient, such individuals are usually prescribed bifocallenses.

SUMMARY OF THE INVENTION

This application is directed to intraocular implants for improving thevision of a patient, such as by increasing the depth of focus of an eyeof a patient. The intraocular implants can include a mask having anannular portion with a relatively low visible light transmissionsurrounding a relatively high transmission central portion such as aclear lens or aperture. This construct is adapted to provide an annularmask with a small aperture for light to pass through to the retina toincrease depth of focus, sometimes referred to herein as pin-holeimaging or pin-hole vision correction. The intraocular implant may havean optical power for refractive correction. For example, the mask can beembodied in or combined with intraocular lenses (IOLs). The intraocularimplant may be implanted in any location along the optical pathway inthe eye, e.g., as an implant in the anterior or posterior chamber.

IOLs have been developed that provide a safe and effective surgicalsolution for cataracts. These lenses are surgically implanted afterremoval of a cataractous natural lens of the eye, restoring clarity andproviding a replacement for the optical power that was removed. In asuccessful IOL implantation, the patient is typically emmetropicafterwards, meaning that their eye is focused for distance. However,conventional IOLs cannot accommodate to focus at different distances, sothe patient typically needs additional correction (e.g., readingglasses) to see near objects clearly. Intraocular implants disclosedherein provide an improvement over presently available IOLs byincorporating a “mask” in the form of an aperture that improves depth offocus.

In certain embodiments, an intraocular device includes a lens body. Thelens body includes an anterior and posterior surface. The posteriorsurface includes a first convex portion, a second concave portion and athird convex portion. The second concave portion is adjacent the firstconvex portion and the third convex portion. The third convex portion isannular and surrounds the second concave portion, and the second concaveportion is annular and surrounds the first convex portion. An opticalpower between the first convex portion and the anterior surface ispositive and an optical power between the third convex portion and theanterior surface is positive. The lens body further includes a maskpositioned between the second concave portion and the anterior surface.

In certain embodiments, a lens body of an intraocular device includes afirst surface and a second surface. A first portion of the first surfaceis convex, a second portion of the first surface is concave, and a thirdportion of the first surface is convex. The second portion is adjacentthe first portion and the third portion. The lens body further includesa mask positioned to block a substantial portion of optical aberrationsthat would be created by the light passing through the second portion ofthe first surface.

In certain embodiments, an intraocular device includes a lens body witha positive optical power. The lens body includes an outer region and arecessed central region. At least a portion of the recessed centralregion includes a thickness less than at least a portion of the outerregion. The lens body further includes a mask coupled with a curvedtransition between the outer region the recessed central region.

In certain embodiments, a method of making an intraocular deviceincludes providing a lens body with a first surface and a secondsurface. The method further includes forming a convex surface on a firstportion of the first surface, a concave surface on a second portion ofthe first surface and a convex surface on a third portion of the firstsurface. The second portion is adjacent the first portion and the thirdportion. The method also includes attaching a mask to the lens body thatis positioned to block a substantial portion of the light passingthrough the second portion of the first surface.

In certain embodiments, a method of making an intraocular deviceincludes forming a rod with an optically transparent inner region alonga length of the rod, an optically transparent outer region along thelength of the rod and a substantially optically non-transparent regionalong the length of the rod between the inner region and the outerregion. The substantially non-transparent region can be a middle region,as discussed below. The method also can include sectioning the rod alonga plane substantially perpendicular to an axis parallel to the length ofthe rod to form a lens body with a first surface and a second surface.The method also can include forming a convex surface on a first portionof the first surface. The first portion can correspond to the innerregion of the sectioned rod. The method can include forming a concavesurface on a second portion of the first surface. The second portion cancorrespond to the non-transparent region. The method can include forminga convex surface on a third portion of the first surface. The thirdportion can correspond to the outer region. The second portion isadjacent the first portion and the third portion. In some embodiments,the non-transparent region is positioned such that, in use, thenon-transparent region blocks a substantial portion of the light passingthrough the second portion of the first surface.

In certain embodiments, a method of making an intraocular deviceincludes forming a lens body around a mask. The mask includes anaperture and an annular region, and the lens body comprising a firstsurface and a second surface. The method further includes forming aconvex surface on a first portion of the first surface, a concavesurface on a second portion of the first surface and a convex surface ona third portion of the first surface. The second portion is adjacent thefirst portion and the third portion. Forming the lens body around themask includes locating the mask within the lens body such that, in use,the mask blocks a substantial portion of the light passing through thesecond portion of the first surface.

In certain embodiments, an intraocular implant includes an implant body.The implant body can include a pin-hole aperture in the implant body,and a mask substantially around the pin-hole aperture. The implant bodycan further include an outer hole region substantially outside an outerperimeter of the mask. The outer hole region can include at least oneouter hole and at least one connection portion. An outer region of theimplant body can be attached to the mask by the at least one connectionportion.

In some embodiments, an intraocular device includes a lens bodycomprising a surface with a transition zone, the transition zoneconfigured to reduce a thickness of the lens body along an optical axisof the lens body, and a mask configured to block a substantial portionof optical aberrations that would be created by light passing throughthe transition zone.

In further embodiments, an intraocular device includes a lens bodycomprising a first surface and a second surface. The first surfacecomprises a first portion, a second portion and a third portion. Anoptic axis of the lens body passes through the first portion, and thesecond portion is between the first portion and the third portion. Theintraocular device can also include a mask positioned between the secondsurface and the second portion of the first surface. A distance from thefirst portion neighboring the second portion to a plane perpendicular tothe optic axis and tangent to the second surface can comprise a firstdistance, and a distance from the third portion neighboring the secondportion to the plane perpendicular to the optic axis and tangent to thesecond surface can comprise a second distance greater than the firstdistance.

In other embodiments, a method for improving the vision of a patientincludes providing an intraocular device comprising a lens bodycomprising a surface with a transition zone. The transition zone can beconfigured to reduce a thickness of the lens body along an optic axis ofthe lens body, and the intraocular device can further include a maskconfigured to block a substantial portion of optical aberrations thatwould be created by light passing through the transition zone. Themethod can further include inserting the intraocular device into anintraocular space of an eye.

In certain embodiments, an intraocular implant includes an implant bodycomprising an outer surface that includes a posterior surface and ananterior surface, an opaque mask positioned between the posteriorsurface and the anterior surface of the implant body. The maskcomprising an aperture. The intraocular implant can further include asupport member coupled to the mask and extending from the mask to theouter surface of the implant body. The support member can extend fromthe mask to the posterior surface of the implant body. A first portionof the support member neighboring the mask can have a firstcross-sectional area parallel the mask and a second portion of thesupport member neighboring the posterior surface can have a secondcross-sectional area parallel the mask that is less than the firstcross-sectional area. The support member may be configured to beremovable from the intraocular implant. The support member may include aplurality of holes characterized in that at least one of the hole size,shape, orientation, and spacing of the plurality of holes is varied toreduce the tendency of the holes to produce visible diffractionpatterns.

In certain embodiments, a method of making an intraocular implantincludes providing an opaque mask comprising an aperture and at leastone support member coupled to the mask, positioning the mask within amold chamber such that the at least one support member is coupled to themold chamber so that the mask resists movement, and flowing a lensmaterial into the mold chamber so that at least a portion of the mask isencased within the lens material. The method may further includeremoving at least a portion of the at least one support member afterinjecting the lens material.

In other embodiments, a method of making an intraocular implant includescoupling an opaque mask comprising an aperture to a surface of a moldchamber, and flowing a lens material into the mold chamber to form anoptic coupled to the mask.

In further embodiments, a method of making an intraocular implantincludes removing a portion of a surface of an optic to form an annularcavity around an aperture region, at least partially filling the cavitywith an opaque material, removing at least some of the aperture regionand a central region of the optic to reduce a thickness of the apertureregion of the optic. At least some of the opaque material may remain onthe surface of the optic to form an opaque mask.

In another embodiment, a method of making an intraocular implantincludes providing an optic with an annular cavity around an apertureregion, at least partially filling the cavity with an opaque material,removing at least some of the aperture region and a central region ofthe optic to reduce a thickness of the aperture region of the optic. Atleast some of the opaque material can remain on the surface of the opticto form an opaque mask.

In even further embodiments, a method of making an intraocular implantincludes positioning an opaque mask with an aperture within a moldcavity such that the mask is not in physical contact with the moldcavity, and injecting an implant body material into the mold cavity toform an implant body around the mask. For example, the mask can bepositioned with magnetic fields or with wires extending from the mask toa frame outside of the mold cavity.

In certain embodiments, a intraocular implant includes an implant bodycomprising a body material and a mask with an aperture positioned withinthe implant body. The mask can include a plurality of holes that extendbetween a posterior surface and an anterior surface of the mask. Thebody material can extend through the plurality of holes of the mask, andthe plurality of holes can be characterized in that at least one of thehole size, shape, orientation, and spacing of the plurality of holes isvaried to reduce the tendency of the holes to produce visiblediffraction patterns. The plurality of holes may be positioned atirregular locations. A first plurality of the holes may include firsthole size, shape or spacing and at least another plurality of holes mayinclude a second hole size, shape, or spacing different from the firstholes size, shape, or spacing. A first plurality of the holes mayinclude first hole size, a second plurality of the holes may include asecond hole size different from the third hole size, and a thirdplurality of holes may include a third hole size different from thefirst holes size and the second hole size.

In certain embodiments, an intraocular implant includes an implant bodyconfigured to be implanted into a sulcus region of an eye of a patient.The implant body can include an aperture that is at least partiallysurrounded by an opaque region forming a mask and an outer hole regionsubstantially outside an outer perimeter of the mask. The outer holeregion can include at least one outer hole and at least one connectionportion, and the outer hole region can have an incident visible lighttransmission of at least 90%. The implant body may also include an outerregion attached to the mask by the at least one connection portion.

In other embodiments, a method of making an intraocular implant includesproviding an implant body configured to be implanted into a sulcusregion of an eye of a patient, forming an aperture in the implant bodyby removing a portion of the implant body, and forming at least oneopening between the outer edge of the structure and a opaque mask regionthat neighbors the aperture.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a front plan view of an embodiment of an intraocularlens with a recessed central region on the posterior surface asdescribed herein.

FIG. 1B illustrates a cross-sectional view of the intraocular lens ofFIG. 1A.

FIG. 2A illustrates a front plan view of an embodiment of an intraocularlens with a recessed central region on the anterior surface as describedherein.

FIG. 2B illustrates a cross-sectional view of the intraocular lens ofFIG. 2A.

FIG. 3A illustrates a front plan view of an embodiment of an intraocularlens with a recessed central region on the posterior surface andanterior surface as described herein.

FIG. 3B illustrates a cross-sectional view of the intraocular lens ofFIG. 3A.

FIG. 4A illustrates a front plan view of an embodiment of an intraocularlens with two transition zones and two masks as described herein.

FIG. 4B illustrates a cross-sectional view of the intraocular lens ofFIG. 4A.

FIG. 5A illustrates a front plan view of an embodiment of an intraocularlens with two transition zones and a single mask as described herein.

FIG. 5B illustrates a cross-sectional view of the intraocular lens ofFIG. 5A.

FIG. 6A illustrates a front plan view of an embodiment of an intraocularlens with a concave posterior surface and a positive optical power asdescribed herein.

FIG. 6B illustrates a cross-sectional view of the intraocular lens ofFIG. 6A.

FIG. 7A illustrates a front plan view of an embodiment of an intraocularlens with a concave posterior surface and a negative optical power asdescribed herein.

FIG. 7B illustrates a cross-sectional view of the intraocular lens ofFIG. 7A.

FIG. 8 is a cross-sectional schematic representation of light passingthrough the intraocular lens of FIG. 2B.

FIG. 9 is a schematic representation of light from a far objecttransmitted through an eye having an embodiment of an intraocular lensthat is in the capsular bag.

FIG. 10A illustrates a top view of a conventional intraocular lens.

FIG. 10B illustrates a cross-sectional view of the conventionalintraocular lens of FIG. 10A.

FIG. 11A is a perspective view of one embodiment of a mask.

FIG. 11B is a perspective view of an embodiment of a substantially flatmask.

FIG. 12 is a side view of an embodiment of a mask having varyingthickness.

FIG. 13 is a side view of another embodiment of a mask having varyingthickness.

FIG. 14 is a side view of an embodiment of a mask with a material toprovide opacity to the mask.

FIG. 15 is an enlarged, diagrammatic view of an embodiment of a maskthat includes particulate structure adapted for selectively controllinglight transmission through the mask in a low light environment.

FIG. 16 is a view of the mask of FIG. 15 in a bright light environment.

FIG. 17 is another embodiment of a mask that includes connectors forsecuring the mask within the eye.

FIG. 18A is a top view of another embodiment of a mask configured toincrease depth of focus.

FIG. 18B is an enlarged view of a portion of the view of FIG. 18A.

FIG. 19 is a cross-sectional view of the mask of FIG. 18B taken alongthe section plane 19-19.

FIG. 20A is a graphical representation of one arrangement of holes of aplurality of holes that may be formed on the mask of FIG. 18A.

FIG. 20B is a graphical representation of another arrangement of holesof a plurality of holes that may be formed on the mask of FIG. 18A.

FIG. 20C is a graphical representation of another arrangement of holesof a plurality of holes that may be formed on the mask of FIG. 18A.

FIG. 21A is an enlarged view similar to that of FIG. 18A showing avariation of a mask having non-uniform size.

FIG. 21B is an enlarged view similar to that of FIG. 18A showing avariation of a mask having a non-uniform facet orientation.

FIG. 22 is a top view of another embodiment of a mask having a holeregion and a peripheral region.

FIG. 23 is a flow chart illustrating one method for making a maskedintraocular implant from a mask comprising a highly fluorinated polymerand an opacification agent.

FIG. 24A is a top plan view of an embodiment of a mask configured toincrease depth of focus as described herein.

FIG. 24B is a front plan view of an embodiment of a mask configured toincrease depth of focus as described herein.

FIG. 24C is a front plan view of an embodiment of a mask configured toincrease depth of focus as described herein.

FIG. 24D is a front plan view of an embodiment of a mask configured toincrease depth of focus as described herein.

FIG. 25A is a cross-sectional view of an embodiment of an intraocularimplant with a mask coupled to the anterior surface of a transition zoneas described herein.

FIG. 25B is a cross-sectional view of an embodiment of an intraocularimplant with a mask coupled to the posterior surface as describedherein.

FIG. 25C is a cross-sectional view of an embodiment of an intraocularimplant with a mask embedded within the implant body about midwaybetween the posterior and anterior surfaces as described herein.

FIG. 25D is a cross-sectional view of an embodiment of an intraocularimplant with a mask embedded within the implant body which is closer tothe anterior surface than the posterior surface as described herein.

FIG. 25E is a cross-sectional view of an embodiment of an intraocularimplant with a mask embedded within the implant body which is closer tothe posterior surface than the anterior surface as described herein.

FIG. 25F is a cross-sectional view of an embodiment of an intraocularimplant with a mask embedded within the implant body and within closeproximity of the anterior surface of a transition zone as describedherein.

FIG. 25G is a cross-sectional view of an embodiment of an intraocularimplant with a mask that extends between the anterior and posteriorsurfaces as described herein.

FIG. 26A is a front plan view of an embodiment of an intraocular implantwith support members extending from the mask to a peripheral surface ofthe implant body as described herein.

FIG. 26B is a cross-sectional view of an embodiment of an intraocularimplant with support members extending from the mask to the posteriorsurface of the implant body as described herein.

FIG. 26C is a cross-sectional view of an embodiment of an intraocularimplant with a mask integrated with the support members as describedherein.

FIG. 27A is a cross-sectional view of an embodiment of an intraocularimplant with tabs extending from the mask to the posterior surface ofthe implant body as described herein.

FIG. 27B is a cross-sectional view of the intraocular implant of FIG.27A wherein a portion of the tabs have been removed.

FIG. 28A is a front plan view of an embodiment of an intraocular implantwith a support member as described herein.

FIG. 28B is a cross-sectional view of the intraocular implant of FIG.28A.

FIG. 29A is a front plan view of an embodiment of an intraocular implantwith a different optical power than the intraocular implant of FIG. 27A.

FIG. 29B is a cross-sectional view of the intraocular implant of FIG.29A.

FIG. 30A is a front plan view of an embodiment of an intraocular lenswith a mask that extends radially beyond the outer periphery of thetransition zone as described herein.

FIG. 30B is a cross-sectional view of the intraocular implant of FIG.30A.

FIG. 31A is a front plan view of another embodiment of an intraocularimplant with a support member as described herein.

FIG. 31B is a cross-sectional view of the intraocular implant of FIG. 31A.

FIG. 32A is a front plan view of another embodiment of an intraocularimplant with a mask that extends radially beyond the outer periphery ofthe transition zone as described herein.

FIG. 32B is a cross-sectional view of the intraocular implant of FIG.32A.

FIG. 33A is a front plan view of a further embodiment of an intraocularimplant with a support member as described herein.

FIG. 33B is a cross-sectional view of the intraocular implant of FIG.33A.

FIG. 34A is a front plan view of a further embodiment of an intraocularimplant with a mask that extends radially beyond the outer periphery ofthe transition zone as described herein.

FIG. 34B is a cross-sectional view of the intraocular implant of FIG.34A.

FIG. 35A is a front plan view of an embodiment of an intraocular implantwith a support member coupled with a haptic as described herein.

FIG. 35B is a cross-sectional view of the intraocular implant of FIG.35A.

FIG. 36A is a front plan view of another embodiment of an intraocularimplant with a support member coupled with a haptic as described herein.

FIG. 36B is a cross-sectional view of the intraocular implant of FIG.36A.

FIG. 37A is a cross-section view of an intraocular implant.

FIG. 37B is a cross-section view of the intraocular implant of FIG. 37Awith a cavity formed into the implant body.

FIG. 37C is a cross-section view of the intraocular implant of FIG. 37Bwith the cavity at least partially filled with an opaque material.

FIG. 37D is a cross-sectional view of the intraocular implant of FIG.37C with a portion of the opaque material and central region removed.

FIG. 38A is a cross-section view of an intraocular implant.

FIG. 38B is a cross-section view of the intraocular implant of FIG. 38Awith a cavity formed into the implant body.

FIG. 38C is a cross-section view of the intraocular implant of FIG. 38Bwith mask positioned within the cavity.

FIG. 38D is a cross-section view of the intraocular implant of FIG. 38Cwith the cavity at least partially filled with an implant body material.

FIG. 38E is a cross-section view of the intraocular implant of FIG. 38Dwith a portion of the implant body removed.

FIG. 39A is a cross-section view of an intraocular implant.

FIG. 39B is a cross-section view of the intraocular implant of FIG. 38Awith a cavity formed into the implant body.

FIG. 39C is a cross-section view of the intraocular implant of FIG. 39Bwith the cavity at least partially filled with an opaque material.

FIG. 39D is a cross-sectional view of the intraocular implant of FIG.39C with a portion of the opaque material and central region removed.

FIG. 40 is a schematic of an embodiment of a mask positioning system forpositioning a mask within a mold cavity as described herein.

FIG. 41 is an illustration of an embodiment of a mask positioningapparatus that includes wires coupled to a mask and a frame as describedherein.

FIG. 42 is a side view of an embodiment of a mask levitated with amagnetic field as described herein.

FIG. 43A is a top view of an embodiment of a mask levitated above ofmagnetic fields as described herein.

FIG. 43B is a top view of another embodiment of a mask levitated aboveof magnetic fields as described herein.

FIG. 44 is a schematic of an embodiment of using electrostaticlevitation to position a mask as described herein.

FIG. 45 is a top view of an embodiment of a bistable display that iscapable of forming a mask as described herein.

FIG. 46 is a top perspective view of an embodiment of a maskedintraocular implant configured to increase depth of focus describedherein.

FIG. 47 is a top plan view of the intraocular implant of FIG. 46.

FIG. 48A is a side elevational view of an embodiment of an intraocularimplant with a mask through the intraocular implant of FIG. 46.

FIG. 48B is a side elevational view of an embodiment of an intraocularimplant with a mask on the posterior surface of the intraocular implant.

FIG. 48C is a side elevational view of an embodiment of an intraocularimplant with a mask on the anterior surface of the intraocular implant.

FIG. 48D is a side elevational view of an embodiment of an intraocularimplant with a mask positioned midway between the posterior and anteriorsurfaces of the intraocular implant.

FIG. 48E is a side elevational view of an embodiment of an intraocularimplant with a mask positioned between the posterior surface and amidway position between the posterior and anterior surfaces of theintraocular implant.

FIG. 48F is a side elevational view of an embodiment of an intraocularimplant with a mask positioned between the anterior surface and a midwayposition between the posterior and anterior surfaces of the intraocularimplant.

FIG. 49A is a top perspective view of an embodiment of an intraocularimplant with five outer holes described herein.

FIG. 49B is a top plan view of the intraocular implant of FIG. 56A.

FIG. 49C is a side elevational view of the intraocular implant of FIG.56A.

FIG. 50A is a top perspective view of an embodiment of an intraocularimplant with a different haptic than the intraocular implant of FIG. 56Adescribed herein.

FIG. 50B is a top plan view of the intraocular implant of FIG. 57A.

FIG. 50C is a side elevational view of the intraocular implant of FIG.57A.

FIG. 51A is a top plan view of an embodiment of an intraocular implantwith a single outer hole described herein.

FIG. 51B is a top plan view of an embodiment of an intraocular implantwith two outer holes described herein.

FIG. 51C is a top plan view of an embodiment of an intraocular implantwith three outer holes described herein.

FIG. 51D is a top plan view of an embodiment of an intraocular implantwith four outer holes described herein.

FIG. 51E is a top plan view of an embodiment of an intraocular implantwith six outer holes described herein.

FIG. 52 is a top plan view of an embodiment of an intraocular implantwith an outer hole region that extends out near the periphery of theimplant body described herein.

FIG. 53A is a top plan view of an embodiment of an intraocular implantwith an outer hole region that extends out further away from theaperture in one direction than another described herein.

FIG. 53B is a top plan view of an embodiment of an intraocular implantwith non-uniform outer holes described herein.

FIG. 54 is a top plan view of an embodiment of an intraocular implantwith an outer hole region that partially surrounds the aperturedescribed herein.

FIG. 55 is a top plan view of an embodiment of an intraocular implantwith a centrally located aperture and an off-center outer hole regiondescribed herein.

FIG. 56 is a top plan view of an embodiment of an intraocular implantwith a centrally located outer hole region and an off-center aperturedescribed herein.

FIG. 57 is a top plan view of an embodiment of an intraocular implantwherein the mask includes light transmission holes described herein.

FIG. 58 is a top plan view of an embodiment of an intraocular implantwith light transmission holes gradually increasing in size radially outfrom the aperture.

FIG. 59 is a plot of visual acuity as a function of defocus comparingtwo typical multifocal IOLs and an embodiment of an ophthalmic devicewith an aperture described herein.

DETAILED DESCRIPTION

This application is directed to intraocular implants and methods ofimplanting intraocular implants. The natural lens of an eye is oftenreplaced with an intraocular lens when the natural lens has been cloudedover by a cataract. An intraocular lens may also be implanted into theeye to correct other refractive defects without removing the naturallens. The intraocular implants of the preferred embodiments include amask adapted to provide a small aperture for light to pass through tothe retina to increase depth of focus, sometimes referred to herein aspinhole imaging or pinhole vision correction. The intraocular implantsmay be implanted in the anterior chamber or the posterior chamber of theeye. In the posterior chamber, the implants may be fixated in theciliary sulcus, in the capsular bag, or anywhere an intraocular implantis fixated. In some embodiments discussed below, the intraocular lenseshave a reduced thickness in a central region compared to conventionalintraocular lenses. The reduced thickness in the central region can helpimprove implantation of the intraocular lens. In further embodimentsdiscussed below, intraocular implants can have an outer hole region(e.g. perforated region) to improve a patient's low light vision.

I. Intraocular Implants with Reduced Thickness

Several alternatives to fixed-focus IOLs have been developed, includingmultifocal IOLs and accommodating IOLs that attempt to provide theability to see clearly at both distance and near. Multifocal IOLs doprovide good acuity at both distance and near, but these lensestypically do not perform well at intermediate distances and areassociated with glare, halos, and night vision difficulties associatedwith the presence of unfocused light. Accommodating IOLs of severaldesigns have also been developed, but none so far has been able toreplicate the function of the natural crystalline lens. IOLs withapertures have been described by Vorosmarthy (U.S. Pat. No. 4,976,732).These devices, however, do not attempt to change focus from far to near,but merely attempt to reduce the blurry image from defocus to a levelwhere a presbyopic emmetrope can read. Notably, Vorosmarthy did notaddress the issue of reducing thickness of a masked IOL for applicationin small-incision surgery.

Some embodiments of the present application provide a masked IOL with athinner optic than has been known in the art. The advantage to a thinneroptic is that the IOL can be inserted through a smaller incision intothe eye. Since corneal incisions tend to distort the cornea and impairvision, reducing the size of the incision will improve the quality ofvision. The optic is made thinner by means similar to a Fresnel lens,where alternating concentric zones provide focusing power and heightsteps. While the thickness reduction possible with a Fresnel lens issignificant, the height steps are optically inappropriate for clinicalapplication. They do not focus light to an image at the fovea, butinstead scatter light, leading to dysphotopsias (streaks, shadows,halos, etc.) in the patient's vision. By combining Fresnel-type heightsteps with a mask that blocks light from passing through the steps andallows light to pass only through the focusing surfaces, one caneliminate the dysphotopsias associated with a common Fresnel lens,obtaining the benefit of reduced thickness without introducing unwantedoptical effects.

Generally, intraocular implants are implanted into the eye by rolling upan intraocular implant and inserting the rolled up intraocular implantinto a tube. The tube is inserted into an incision in the eye, and theintraocular implant is ejected out of the tube and deployed within theeye. Intraocular implants can be implanted within the lens capsule afterremoval of the natural lens, or in the anterior chamber, posteriorchamber, and can be coupled with or attached to the ciliary sulcus(sometimes referred to herein as “sulcus-fixated”). Depending on thelocation of the intraocular implant within the eye, dimensions of theintraocular implant, including but not limited to the aperture of themask, may be adjusted. By reducing the thickness of in the centralregion of the intraocular lens, the intraocular lens can be rolled uptighter and inserted into a smaller tube. A smaller incision can be madein the eye if a smaller tube is used. The result is a less invasiveprocedure with quicker recovery time for the patient. Also, comparedwith a conventional posterior chamber phakic intraocular lens, a reducedthickness lens that is fixated in the ciliary sulcus will allow morespace between the intraocular lens posterior surface and the naturalcrystalline lens surface, thereby reducing the potential for contactbetween these surfaces.

In certain embodiments, an intraocular lens 100 includes a lens body 102with an optical power to refract light and correct refractive errors ofthe eye. Certain embodiments are illustrated in FIGS. 1-10. Theintraocular lens 100 may include one or more haptics 104 to prevent theintraocular lens 100 from moving or rotating within the eye. As usedherein the term “haptic” is intended to be a broad term encompassingstruts and other mechanical structures that can be apposed against aninner surface of an eye and mounted to a lens structure to securelyposition a lens in an optical path of an eye. The haptics 104 can be avariety of shapes and sizes depending on the location the intraocularlens 100 is implanted in the eye. Haptics illustrated in FIGS. 1-10 canbe interchanged with any variety of haptic. For example, the hapticsillustrated in FIGS. 1-10 can be combined with the intraocular lensillustrated in FIGS. 1-10. Haptics may be C-shaped, J-shaped, platedesign, or any other design. An intraocular implant described herein mayhave two, three, four, or more haptics. The haptics may be of open orclosed configuration and may be planar, angled, or step-vaulted.Examples of haptics are disclosed in U.S. Pat. Nos. 4,634,442;5,192,319; 6,106,553; 6,228,115; Re. 34,251; 7,455,691; and U.S. PatentApplication Publication 2003/0199978, which are incorporated in theirentirety by reference.

In certain embodiments, the lens body 102 includes a posterior surface110 and an anterior surface 112, as illustrated in FIGS. 1A-B. The lensbody 102 includes a first portion 116 (e.g., inner portion or centralregion), a second portion 114 (e.g., transition zone) and a thirdportion 118 (e.g., outer portion or region) on the posterior surface110. The second portion 114 can be between and/or adjacent the firstportion 116 and the third portion 118. The second portion 114 cansubstantially surround the first portion 116, and the third portion 118can substantially surround the second portion 114. In certainembodiments, the first portion 116 is substantially circular, and thesecond portion 114 and third portion 118 are substantially annular. Thefirst portion 116 and third portion 118 can refract light or have anoptical power to improve a patient's vision. The second portion 114 hasone or more facets, grooves, crests, troughs, depressions, contours,surface curvatures, etc. to make the first portion 116 closer to theanterior surface 112 than if the posterior surface 110 did not have thesecond portion 114. The second portion 114 can also be described as a“transition zone” between the first portion 116 and the third portion118. For example, the second portion 114 transition zone can slopetoward the anterior surface 112 from the third portion 118 to the firstportion 116. In certain embodiments, the second portion 114 transitionzone includes a surface substantially perpendicular to the anteriorsurface 112. The transition zones are like those incorporated in aFresnel lens. They enable the lens body to be made thinner than would berequired in a conventional lens design. However, as with Fresnel lenses,the transition zones introduce optical aberrations that would not beclinically acceptable in intraocular lenses.

The intraocular lens 100 can include a mask 108 that can be positionedto block a substantial portion of light that would pass through thesecond portion 114 transition zone of the posterior surface 110.“Blocked” as used in this context includes preventing at least a portionof light from passing through the mask, as well as preventingsubstantially all the light from passing through the mask. If the mask108 did not block the light rays that would pass through the secondportion 114, aberrations would result since the refraction of light(e.g. optical power, etc.) in the second portion 114 is typicallydifferent than in the first portion 116 and the third portion 118.

In certain embodiments, the first portion 116 is convex, the secondportion 114 is concave, and the third portion 118 is convex. In certainembodiments, the first portion 116 and the third portion 118 have apositive or converging optical power and the second portion 114 has anegative or diverging optical power. The second portion 114 may havecurvature or no curvature in a direction extending radially from thefirst portion 116 to the third portion 118. For example, the secondportion 114 may have a positive or negative curvature (e.g., convex orconcave) in a direction extending radially from the first portion 116 tothe third portion 118. Furthermore, the second portion 114 may form aclosed loop and have surface similar to an outer surface of afrustoconical shape.

In certain embodiments, the first portion 116 is within a central region132 of the lens body 102. The central region 132 can be recessed withinthe lens body 102. In certain embodiments, the third portion 118 iswithin an outer region 130 of the lens body 102. In certain embodiments,an outer perimeter of the first portion 116 is surrounded and/orenclosed by an inner perimeter of the second portion 114. In certainembodiments, an outer perimeter of the second portion 114 is surroundedand/or enclosed by an inner perimeter of the third portion 118. Incertain embodiments, the maximum thickness of the lens body 102 in theregion of the first portion 116 is less than the maximum thickness ofthe lens body 102 in the region of the second portion 114.

In certain embodiments, a lens body 202 includes a first portion 222, asecond portion 220 and a third portion 224 on the anterior surface 212,as illustrated in FIGS. 2A-B. The first portion 222, the second portion220 and the third portion 224 on the anterior surface 212 can havesimilar features as described above for the first portion 116, thesecond portion 114 and the third portion 118 on the anterior surface112. The intraocular lens 200 can include a mask 208 that is positionedto block a substantial portion of light that passes through the secondportion 220 of the anterior surface 212.

In certain embodiments, both an anterior surface 312 and a posteriorsurface 310 have a first portion 316, 322, a second portion 314, 320 anda third portion 318, 324, as illustrated in FIGS. 3A-B. A mask 308 canbe positioned so that a substantial portion of the light that passesthrough the second portion 320 of the anterior surface 312 and the lightthat would pass through the second portion 314 of the posterior surface310 will be blocked by the mask 308.

In certain embodiments, the mask is coupled with the second portion,which is concave. For example, the mask can be located adjacent thesecond portion. In certain embodiments, the mask is attached to theposterior surface, the anterior surface, or the posterior and theanterior surfaces. In certain embodiments, the mask is within the lensbody or between the posterior surface and the anterior surface. Theradial width or the area of the mask can be about the same as the radialwidth or the area of the second portion. In certain embodiments, themask can extend at least partially into the area of the first portionand/or the third portion of the lens body. By extending the mask intothe first portion and/or the third portion, the mask can block lightthat enters at large angles off the optical center axis of the lens bodyand that may then pass through the second portion.

Illustrated in FIGS. 4A-B, an intraocular lens 400 can further include afourth portion 420 b and a fifth portion 424 b on the anterior surface412 and/or the posterior surface 410. The fourth portion 420 b isadjacent the third portion 424 a and can substantially surround thethird portion 424 a. The fifth portion 424 b is adjacent the fourthportion 420 b and can substantially surround the fourth portion 420 b.The fourth portion 420 b can have similar features as described abovefor the second portion 420 a, and the fifth portion 424 b can havesimilar features as described above for the third portion 424 a. Theintraocular lens 400 can include a first mask 408 a that is positionedto block a substantial portion of light that passes through the secondportion 420 a of the anterior surface 412, and a second mask 408 b thatis positioned to block a substantial portion of light that passesthrough the fourth portion 420 b of the anterior surface 412. It shouldbe understood that additional pairs of portions with a mask like thefourth portion 420 b, the fifth portion 424 b and the second mask 408 bcan be further included in an intraocular lens.

FIGS. 5A-B illustrate an intraocular lens 500 similar to the intraocularlens 400 illustrated in FIGS. 4A-B. Instead of the intraocular lens 400having a first mask 408 a and a second mask 408 b, the intraocular lens500 has a single mask 508 with a plurality of light transmission holesthat allow at least partial light transmission through the mask 508. Thelight transmission holes can be configured to allow substantially nolight that passes through the second portion 520 a and the fourthportion 520 b to pass through the mask 508, but allow at least somelight that passes through the third portion 524 a to pass through themask 508. For example, a middle annular region of the mask can have aplurality of holes to allow at least some light to pass through themask, and an inner annular region and an outer annular region can havesubstantially no holes. Light transmission structures or holes arefurther discussed in sections below and can be applied to embodimentsdiscussed herein.

The variety of intraocular lenses described herein are designed to suitthe vision correction needs of particular patients. For example, forpatients with relatively small pupils, dim light may present more of avision issue than for patients with larger pupils. For smaller pupilpatients, a mask with more light transmission and/or a smaller outerdiameter will increase the amount of light that reaches the retina andmay improve vision in dim light situations. Conversely, for larger pupilpatients, less light transmission and/or a larger outer diameter maskmay improve low-contrast near vision and block more unfocused light. Themasked IOLs described herein give the surgeon flexibility to prescribethe appropriate combination of masked IOL features for particularpatients.

FIGS. 6-7 illustrate additional embodiments of intraocular lenses 600,700. The posterior surface and anterior surface of an intraocular lenscan have a variety of curvatures. For example, the posterior surfaceand/or the anterior surface can be concave or convex. FIGS. 6A-Billustrates an intraocular lens 600 with a concave posterior surface 610with an anterior surface 612 to create a positive optical power lens.FIGS. 7A-B illustrate an intraocular lens 700 with a concave posteriorsurface 710 with an anterior surface 712 to create a negative opticalpower lens. Both intraocular lenses 600, 700 have a second portion 620,720 to reduce the overall thickness of the intraocular lenses 600, 700.Both intraocular lenses 600, 700 also can include a mask 608, 708 toblock light that passes through the second portion 620, 720. Fornegative power intraocular lenses, such as the intraocular lens 700 ofFIG. 7, the thickness of the central region 732 of the lens body 702 maynot be reduced by the second portion 720. However, the thickness of theouter region 730 of the lens body 702 can be reduced by the secondportion 720 (e.g., transition zone). Advantageously, if an intraocularlens has a positive optical power or a negative optical power, thethickness of at least a portion of the lens body can be reduced byhaving the lens body include a second portion.

Tables I and II illustrate examples of intraocular lens with reducedlens body thicknesses. The column labeled “Reduced” corresponds to anintraocular lens with a second portion (e.g. transition zone), and thecolumn labeled “Original” is corresponds to an intraocular lens withouta second portion. The optic diameter is the diameter of the outer-mostportion of the lens body with an optical power. The reduction percentageof the center region thickness indicated in Tables I and II can be aboutproportional to the reduction in the possible rolled up diameter of areduced thickness IOL. Therefore, the reduction percentage of the centerregion thickness indicated in Tables I and II can also be aboutproportional to the reduction in the incision size that can be usedduring implantation of the IOL in a patient. An IOL is rolled up andinserted into a tube, and the tube is inserted into the incision. TheIOL can then be deployed into the intraocular space of the eye. The IOLis often rolled up as tight as possible so that open space (e.g., voids)is minimized in a cross-section of the tube at a location where theimplant body has the greatest cross-sectional area that is generallyparallel with the optical axis of the implant body. Therefore, thecross-sectional area of the tube is greater than or equal to thegreatest cross-sectional area of the implant body that is generallyparallel with the optical axis of the implant body. For example, a 36%reduction in the cross sectional area of the implant body could reducethe cross sectional area of the tube by 36% or could reduce the diameterof the tube by about 20%. A minimum incision length is generallyone-half of the circumference of the tube. Therefore, a 36% reduction inthe cross sectional area of the implant body can result in about 20%reduction in incision length. For example, a 1.8 mm incision could bereduced to about 1.44 mm. A smaller incision is beneficial because itavoids post-operative astigmatism.

TABLE I Examples of reduced thickness IOLs with positive optical power.Center region thickness Cross section area of center Optic Material [mm]region [mm²] Diameter [Ref. Reduction Reduction [mm] index] DiopterOriginal Reduced [%] Original Reduced [%] Biconvex IOL 5.5 1.4300 18.00.94 0.42 55 3.96 2.48 37 5.5 1.4300 24.0 1.20 0.56 53 4.93 3.13 37 5.51.4583 18.0 0.77 0.32 58 3.32 2.05 38 5.5 1.4583 24.0 0.96 0.42 56 4.022.51 38 6.0 1.4300 18.0 1.08 0.50 54 4.76 3.08 35 6.0 1.4300 24.0 1.400.62 56 6.04 3.85 36 6.0 1.4583 18.0 0.87 0.37 57 3.92 2.50 36 6.01.4583 24.0 1.10 0.50 55 4.88 3.13 36 Sulcus-fixated IOL 5.5 1.4583 5.00.34 0.15 56 1.75 1.22 30 5.5 1.4583 10.0 0.52 0.20 62 2.43 1.51 38 6.01.4583 5.0 0.37 0.17 54 1.95 1.36 30 6.0 1.4583 10.0 0.59 0.21 64 2.861.76 38

TABLE II Examples of reduced thickness IOLs with negative optical power.Cross section area of outer Outer region thickness region Optic Material[mm] [mm{circumflex over ( )}2] Diameter [Ref. Reduction Reduction [mm]index] Diopter Original Reduced [%] Original Reduced [%] Sulcus-fixatedIOL 5.5 1.4583 −5.0 0.26 0.17 35 1.09 0.77 29 5.5 1.4583 −10.0 0.41 0.2539 1.52 0.97 36 6.0 1.4583 −5.0 0.29 0.20 31 1.12 0.77 31 6.0 1.4583−10.0 0.48 0.32 33 1.57 0.99 37

FIG. 8 illustrates the operation of the intraocular lens 200 of FIGS.2A-B. In use, light enters the anterior surface 212, passes through thelens body 202 and exits the posterior surface 210 of the intraocularlens 200. The mask 208 is located such that the mask 208 blocks asubstantial portion of the light rays 850 that pass through the secondportion 220 of the anterior surface 212, as illustrated in FIG. 8. Ifthe mask 208 did not block the light rays 850 that pass through thesecond portion 220, aberrations would result. For example, if thecurvature of the second portion 220 is configured to provide a negativeor divergent optical power, light rays 860 passing through this regionwould diverge and not focus, as illustrated in FIG. 8. The light rays850 that pass through the first portion 222 and/or the third portion 224would have a positive or convergent optical power. If the first portion222 and the third portion 224 have a similar curvature or optical power,light rays 450 entering the anterior surface 212 and passing through thefirst portion 222 and/or the third portion 224 would converge at acommon point 870 after passing through the posterior surface 210, asillustrated in FIG. 8. FIG. 9A illustrates an intraocular lens 200implanted within the capsular bag 954 of an eye 952. Parallel light rays950 that pass through the intraocular lens 200 converge on the retina956.

The lens body 202 can include one or more materials. In certainembodiments, the lens body 202 includes two or more materials. Forexample, the first portion 222 and the third portion 224 can includedifferent materials. If the materials selected for the first portion 222and the third portion 224 have different refractive indexes, thecurvature of the first portion 222 and the third portion 224 can bedifferent to obtain a similar optical power (e.g. dioptric power) forboth portions.

Generally, the optical power of an intraocular lens is selected forfocusing on far objects. A natural lens can deform to change the focaldistance for far and near viewing. Conventional artificial intraocularlenses are generally unable to change the focal distance. For example,an eye that is presbyopic or where an artificial intraocular lens has anoptical power for farther distance, light rays that enter the eye andpass through the cornea and the natural lens or artificial intraocularlens converge at a point behind or in front of the retina and do notconverge at a point on the retina. The light rays strike the retina overa larger area than if the light rays converged at a point on the retina.The patient experiences this as blurred vision, particularly forup-close objects such as when reading. For such conditions, the mask 208of the intraocular lens 200 can be configured with an aperture such thatonly a subset of light rays, e.g. a central portion, are transmitted tothe retina. The mask 208 with an aperture can improve the depth of focusof a human eye. For example, the aperture can be a pin-hole aperture.The mask 208 blocks a portion of the outer light rays resulting in morefocused light rays. The mask 208 can include an annular regionsurrounding an aperture. The aperture can be substantially centrallylocated on the mask. For example, the aperture can be located around acentral axis of the mask, also referred to as the optical axis of themask. The aperture of the mask can be circular or any other shape.

The mask 208 can be positioned in a variety of locations in or on theintraocular lens 200. The mask 208 can be through the lens body 202. Themask 208 can be positioned on the anterior or posterior surface of thelens body 202. In certain embodiments, the mask 208 is embedded withinthe lens body. For example, the mask 208 can be positioned substantiallyat the midway line between the posterior and anterior surfaces of thelens body 202. In certain embodiments, the mask 208 is positionedbetween the midway line and the posterior surface of the lens body 202.Certain embodiments include the mask 208 being positioned midway,one-third or two-thirds between the midway line and the posteriorsurface of the lens body 202. In certain other embodiments, the mask 208is positioned between the midway line and the anterior surface of thelens body 202. Certain embodiments include the mask 208 being positionedmidway, one-third or two-thirds between the midway line and the anteriorsurface of the lens body 202. If the transition zone is on the anteriorsurface of the implant body and the mask is positioned to be on or nearthe surface of the transition zone on the anterior surface, the mask maynot extend beyond the transition zone since light even at large anglesfrom the optical axis that hits or passes through the transition zonesurface would be blocked by the mask.

In certain embodiments, the mask 208 of an intraocular lens 200 has anaperture wherein the mask blocks a portion of the light to improveviewing near objects, similar to a mask discussed above. Advantageously,the mask 208 can provide as an aperture and can block a portion lightthat may not converging on the retina 956 and also block light thatpasses through the second portion 220, creating aberrations, asdescribed above. In certain embodiments, the aperture of the mask 208has a diameter of about 1 to 2 mm. In certain embodiments, the mask 208has an outer perimeter with a diameter of about 3 to 5 mm.

In certain embodiments, the third portion 224 of intraocular lens 200can improve low light vision. As the pupil of the eye enlarges,eventually light rays will enter and pass through the third portion 224of the intraocular lens 200. As illustrated in FIG. 9, if the pupil 958of the eye 952 is large enough so that light rays 950 pass through thethird portion 224 of the intraocular lens 200, additional light rays 950will strike the retina. As discussed above, the intraocular lens 200 canhave an optical power to correct for viewing far objects so that lightrays from a far object are focused at one point on the retina. Nearobjects during low light conditions may result in an unfocused image ifthe intraocular lens 200 has an optical power to view far objects.

The mask 208 can have different degrees of opacity. For example, themask 208 can block substantially all of visible light or may block aportion of visible light. The opacity of the mask 208 may also vary indifferent regions of the mask 208. In certain embodiments, the opacityof the outer edge and/or the inner edge of the mask 208 is less than thecentral region of the mask 208. The opacity in different regions maytransition abruptly or have a gradient transition. Additional examplesof opacity transitions can be found in U.S. Pat. Nos. 5,662,706,5,905,561 and 5,965,330, which are incorporated in their entirety byreference.

A conventional intraocular lens 1000 is illustrated in FIGS. 10A-B. Byhaving a recessed portion on the posterior surface 310 (created bysecond portions 314) and/or the anterior surface 312 (created by secondportion 320) of the lens body 302, the maximum thickness of theintraocular lens 300 is reduced compared to a conventional lens body1002 without such portions, as shown in FIG. 10B. The cross-sectionalthickness of the lens body 1002 is generally dependent on the opticalpower of the intraocular lens 1000 and the material of the lens body1002. In particular, the central region of the lens body 1002 isgenerally the thickest section of the intraocular lens 1000 with acentral region cross-sectional thickness 1006. In certain embodimentsdisclosed herein, a lens body 202 of an intraocular lens 200 has acentral region thickness 206 less than the central region thickness 1006of other common lens bodies. In the embodiment of FIG. 3B, the thickness306 is further reduced compared to a conventional intraocular lens 1000.

Generally, as discussed above, intraocular lenses are implanted into theeye by rolling up an intraocular lens and inserting the rolled upintraocular lens into a tube. One advantage to a thinner lens body isthat it the intraocular lens can be more tightly rolled up resulting inbeing able to use a small tube and a small incision. Another advantageto a thinner lens body is that the intraocular lens can decrease risksassociated with implanting in different locations within the eye. Forexample, an intraocular lens 200 can be implanted within the anteriorchamber. An intraocular lens 200 can also be positioned within theposterior chamber so that the first portion 216 of the posterior surface210 floats above the natural crystalline lens. The potential for contactbetween the posterior surface 210 of the intraocular lens 200 and thenatural crystalline lens will be reduced because the reduced thicknessof the intraocular lens 200. For example, the intraocular lens 200 canbe coupled with or attached to the ciliary sulcus (sometimes referred toherein as “sulcus-fixated”). An intraocular lens 200 can also beimplanted in the capsular bag, as illustrated in FIG. 9. Depending onthe location of the intraocular lens within the eye, dimensions of theintraocular lens 200 including but not limited to the aperture of themask 208 may be adjusted.

The intraocular lens 200 and/or the lens body 202 can be made from oneor more materials. In certain embodiments, the intraocular lens 200and/or the lens body 202 can comprise polymers (e.g. PMMA, PVDF,polypropylene, polycarbonate, PEEK, polyethylene, acrylic copolymers,polystyrene, PVC, polysulfone), hydrogels, and silicone.

II. Masks Providing Depth of Focus Correction

A variety of variations of masks that can be positioned on or within theimplant body 2014 are discussed herein, and also described in U.S. Pat.No. 7,628,810, U.S. Patent Publication No. 2006/0113054, and U.S. PatentPublication No. 2006/0265058 which are hereby incorporated by referencein their entirety. FIG. 11A illustrates one embodiment of a mask 2034 a.The mask 2034 a can include an annular region 2036 a surrounding apinhole opening or aperture 2038 a substantially centrally located onthe mask 2034 a. The pinhole aperture 2038 a can be generally locatedaround a central axis 2039 a, referred to herein as the optical axis ofthe mask 2034 a. The pinhole aperture 2038 a can be in the shape of acircle. FIG. 11B illustrates another embodiment of a mask 2034 b similarto the mask 2034 a illustrated in FIG. 11A. The annular region 2036 a ofthe mask 2034 a of FIG. 11A has a curvature from the outer periphery tothe inner periphery of the annular region 2036 a; while the annularregion 2036 b of the mask 2034 b of FIG. 11B is substantially flat.

The mask can have dimensions configured to function with the implantbody to improve a patient's vision. For example, the thickness of themask can vary depending on the location of the mask relative to theimplant body. For example, if the mask is embedded within the implantbody, the mask can have a thickness greater than zero and less than thethickness of the implant body. Alternatively, if the mask is coupled toa surface of the implant body, the mask may preferably have a thicknessno greater than necessary to have desired opacity so that the mask doesnot add additional thickness to the intraocular lens. In certainembodiments, the mask has a thickness of greater than zero and less thanabout 0.5 mm. In one embodiment, the mask has a thickness of about 0.25mm. If the mask is on or near the surface of the transition zone, themask can have a shape similar or the same as the transition zone.

The mask may have a constant thickness, as discussed below. However, insome embodiments, the thickness of the mask may vary between the innerperiphery (near the aperture 2038) and the outer periphery. FIG. 12shows a mask 2034 k that has a gradually decreasing thickness from theinner periphery to the outer periphery. FIG. 13 shows a mask 20341 thathas a gradually increasing thickness from the inner periphery to theouter periphery. Other cross-sectional profiles are also possible.

The annular region 2036 can be at least partially opaque or can becompletely opaque. The degree of opacity of the annular region 2036prevents at least some or substantially all light from being transmittedthrough the mask 2032. Opacity of the annular region 2036 may beachieved in any of several different ways.

For example, in one embodiment, the material used to make mask 2034 maybe naturally opaque. Alternatively, the material used to make the mask2034 may be substantially clear, but treated with a dye or otherpigmentation agent to render region 2036 substantially or completelyopaque. In still another example, the surface of the mask 2034 may betreated physically or chemically (such as by etching) to alter therefractive and transmissive properties of the mask 2034 and make it lesstransmissive to light.

In still another alternative, the surface of the mask 2034 may betreated with a particulate deposited thereon. For example, the surfaceof the mask 2034 may be deposited with particulate of titanium, gold orcarbon to provide opacity to the surface of the mask 2034. In anotheralternative, the particulate may be encapsulated within the interior ofthe mask 2034, as generally shown in FIG. 14. Finally, the mask 2034 maybe patterned to provide areas of varying light transmissivity.

In another embodiment, the mask may be formed from co-extruded rods madeof material having different light transmissive properties. Theco-extruded rod may then be sliced to provide disks for a plurality ofmasks, such as those described herein.

Other embodiments employ different ways of controlling the lighttransmissivity through a mask. For example, the mask may be a gel-filleddisk, as shown in FIG. 14. The gel may be a hydrogel or collagen, orother suitable material that is biocompatible with the mask material andcan be introduced into the interior of the mask. The gel within the maskmay include particulate 2066 suspended within the gel. Examples ofsuitable particulate are gold, titanium, and carbon particulate, which,as discussed above, may alternatively be deposited on the surface of themask.

The material of the mask 2034 may be any polymeric material. Where themask 2034 is applied to the intraocular implant, the material of themask 2034 should be biocompatible. Where a gel is used, the material issuitable for holding a gel. Examples of suitable materials for the mask2034 include the preferred polymethylmethacrylate or other suitablepolymers or co-polymers, such as hydrogels, and the like. Of course, asindicated above, for non-gel-filled materials, a preferred material maybe a fibrous material, such as a Dacron mesh.

FIGS. 15 and 16 illustrate one embodiment where a mask 2034 w comprisesa plurality of nanites 2068. “Nanites” are small particulate structuresthat have been adapted to selectively transmit or block light enteringthe eye of the patient. The particles may be of a very small sizetypical of the particles used in nanotechnology applications. Thenanites 2068 are suspended in the gel or otherwise inserted into theinterior of the mask 2034 w, as generally shown in FIGS. 15 and 16. Thenanites 2068 can be preprogrammed to respond to different lightenvironments.

Thus, as shown in FIG. 15, in a high light environment, the nanites 2068turn and position themselves to substantially and selectively block someof the light from entering the eye. However, in a low light environmentwhere it is desirable for more light to enter the eye, nanites mayrespond by turning or be otherwise positioned to allow more light toenter the eye, as shown in FIG. 16.

Nano-devices or nanites are crystalline structures grown inlaboratories. The nanites may be treated such that they are receptive todifferent stimuli such as light. In accordance with one aspect ofcertain embodiments, the nanites can be imparted with energy where, inresponse to a low light and high light environments, they rotate in themanner described above and generally shown in FIG. 16.

Nanoscale devices and systems and their fabrication are described inSmith et al., “Nanofabrication,” Physics Today, February 1990, pp. 24-30and in Craighead, “Nanoelectromechanical Systems,” Science, Nov. 24,2000, Vol. 290, pp. 1502-1505, both of which are incorporated byreference herein in their entirety. Tailoring the properties ofsmall-sized particles for optical applications is disclosed in Chen etal. “Diffractive Phase Elements Based on Two-Dimensional ArtificialDielectrics,” Optics Letters, Jan. 15, 1995, Vol. 20, No. 2, pp.121-123, also incorporated by reference herein in its entirety.

In additional embodiments, a photochromic material can be used as themask or in addition to mask. Under bright light conditions, thephotochromic material can darken thereby creating a mask and enhancingnear vision. Under dim light conditions, the photochromic lightens,which allows more light to pass through to the retina. In certainembodiments, under dim light conditions, the photochromic lightens toexpose an optic of the intraocular implant.

The mask can have different degrees of opacity. For example, the maskcan block substantially all of visible light or may block a portion ofvisible light. The opacity of the mask may also vary in differentregions of the mask. In certain embodiments, the opacity of the outeredge and/or the inner edge of the mask is less than the central regionof the mask. The opacity in different regions may transition abruptly orhave a gradient transition. Additional examples of opacity transitionscan be found in U.S. Pat. Nos. 5,662,706, 5,905,561 and 5,965,330, whichare incorporated in their entirety by reference.

In some embodiments, the mask 2034 is attached or fixed to the eye 2010by support strands 2072 and 2074 shown in FIG. 17 and generallydescribed in U.S. Pat. No. 4,976,732, incorporated by reference hereinin its entirety.

Further mask details are disclosed in U.S. Pat. No. 4,976,732, issuedDec. 11, 1990 and in U.S. patent application Ser. No. 10/854,033, filedMay 26, 2004, both of which are incorporated by reference herein intheir entirety.

An advantage to embodiments that include a mask with an aperture (e.g.,pin-hole aperture) described herein over multifocal IOLs, contactlenses, or treatments of the cornea is that all of these latterapproaches divide the available light coming through the aperture intotwo or more foci while a mask approach has a single focus (monofocal).This limitation forces designers of multifocal optics to choose how muchof the light is directed to each focal point, and to deal with theeffects of the unfocused light that is always present in any image. Inorder to maximize acuity at the important distances of infinity (>6M)and 40 cm (normal reading distance), it is typical to provide little orno light focused at an intermediate distance, and as a result, visualacuity at these distances is poor.

With an aperture to increase depth-of-focus, however, the intermediatevision of presbyopic patient is improved significantly. Indeed, thedefocus blur with the pin-hole aperture is less at intermediatedistances than at near. This can be seen in FIG. 59 which is a plot ofvisual acuity as a function of defocus comparing an embodiment of anophthalmic device with an aperture and with two commercially availablemultifocal IOLs. While greater visual acuity is obtained with themultifocal IOLs at very close distances (33 cm, −3D), over the range of1M (−1D) to 40 cm (−2.5D), the pin-hole aperture can outperform amultifocal optic in an intermediate range.

Visual acuity is measured in logMAR and is the log of the minimum angleof resolution or the smallest angular spacing that can be seen, and itis independent of viewing distance. A logMAR value of 0 means 20/20,6/6, or a decimal acuity of 1 at distance, and equivalent to a nearacuity of Jaeger 1 (J1). Defocus is measured in diopters, which are thereciprocal of the eye's focal length in meters. Thus, −1D of defocusmeans the eye is focused at 1/1=1 meter. The standard (US and Europe)reading distance is 40 cm, which is −2.5 D of defocus (1/0.4=2.5).

Iii. UV-Resistant Polymeric Mask Materials

Because the mask has a very high surface to volume ratio and is exposedto a great deal of sunlight following implantation, the mask preferablycomprises a material which has good resistance to degradation, includingfrom exposure to ultraviolet (UV) or other wavelengths of light.Polymers including a UV absorbing component, including those comprisingUV absorbing additives or made with UV absorbing monomers (includingco-monomers), may be used in forming masks as disclosed herein which areresistant to degradation by UV radiation. Examples of such polymersinclude, but are not limited to, those described in U.S. Pat. Nos.4,985,559 and 4,528,311, the disclosures of which are herebyincorporated by reference in their entireties. In a preferredembodiment, the mask comprises a material which itself is resistant todegradation by UV radiation. In one embodiment, the mask comprises apolymeric material which is substantially reflective of or transparentto UV radiation. The lens body may include a UV absorbing component inaddition to the mask being resistant to degradation by UV radiation orthe mask may not be resistant to degradation by UV radiation since theUV absorbing component in the lens body may prevent degradation of themask by UV radiation.

Alternatively, the mask may include a component which imparts adegradation resistive effect, or may be provided with a coating,preferably at least on the anterior surface, which imparts degradationresistance. Such components may be included, for example, by blendingone or more degradation resistant polymers with one or more otherpolymers. Such blends may also comprise additives which providedesirable properties, such as UV absorbing materials. In one embodiment,blends preferably comprise a total of about 1-20 wt. %, including about1-10 wt. %, 5-15 wt. %, and 10-20 wt. % of one or more degradationresistant polymers. In another embodiment, blends preferably comprise atotal of about 80-100 wt. %, including about 80-90 wt. %, 85-95 wt. %,and 90-100 wt. % of one or more degradation resistant polymers. Inanother embodiment, the blend has more equivalent proportions ofmaterials, comprising a total of about 40-60 wt. %, including about50-60 wt. %, and 40-50 wt. % of one or more degradation resistantpolymers. Masks may also include blends of different types ofdegradation resistant polymers, including those blends comprising one ormore generally UV transparent or reflective polymers with one or morepolymers incorporating UV absorption additives or monomers. These blendsinclude those having a total of about 1-20 wt. %, including about 1-10wt. %, 5-15 wt. %, and 10-20 wt. % of one or more generally UVtransparent polymers, a total of about 80-100 wt. %, including about80-90 wt. %, 85-95 wt. %, and 90-100 wt. % of one or more generally UVtransparent polymers, and a total of about 40-60 wt. %, including about50-60 wt. %, and 40-50 wt. % of one or more generally UV transparentpolymers. The polymer or polymer blend may be mixed with other materialsas discussed below, including, but not limited to, opacification agents,polyanionic compounds and/or wound healing modulator compounds. Whenmixed with these other materials, the amount of polymer or polymer blendin the material which makes up the mask is preferably about 50%-99% byweight, including about 60%-90% by weight, about 65-85% by weight, about70-80% by weight, and about 90-99% by weight.

Preferred degradation resistant polymers include halogenated polymers.Preferred halogenated polymers include fluorinated polymers, that is,polymers having at least one carbon-fluorine bond, including highlyfluorinated polymers. The term “highly fluorinated” as it is usedherein, is a broad term used in its ordinary sense, and includespolymers having at least one carbon-fluorine bond (C—F bond) where thenumber of C—F bonds equals or exceeds the number of carbon-hydrogenbonds (C—H bonds). Highly fluorinated materials also includeperfluorinated or fully fluorinated materials, materials which includeother halogen substituents such as chlorine, and materials which includeoxygen- or nitrogen-containing functional groups. For polymericmaterials, the number of bonds may be counted by referring to themonomer(s) or repeating units which form the polymer, and in the case ofa copolymer, by the relative amounts of each monomer (on a molar basis).

Preferred highly fluorinated polymers include, but are not limited to,polytetrafluoroethylene (PFTE or Teflon®), polyvinylidene fluoride (PVDFor Kynar®), poly-1,1,2-trifluoroethylene, and perfluoroalkoxyethylene(PFA). Other highly fluorinated polymers include, but are not limitedto, homopolymers and copolymers including one or more of the followingmonomer units: tetrafluoroethylene —(CF2-CF2)-; vinylidene fluoride—(CF2-CH2)-; 1,1,2-trifluoroethylene —(CF2-CHF)-; hexafluoropropene—(CF(CF3)-CF2)-; vinyl fluoride —(CH2-CHF)— (homopolymer is not “highlyfluorinated”); oxygen-containing monomers such as —(O-CF2)-,—(O-CF2-CF2)-, —(O—CF(CF3)-CF2)-; chlorine-containing monomers such as—(CF2-CFCl)—. Other fluorinated polymers, such as fluorinated polyimideand fluorinated acrylates, having sufficient degrees of fluorination arealso contemplated as highly fluorinated polymers for use in masksaccording to preferred embodiments. The homopolymers and copolymersdescribed herein are available commercially and/or methods for theirpreparation from commercially available materials are widely publishedand known to those in the polymer arts.

Although highly fluorinated polymers are preferred, polymers having oneor more carbon-fluorine bonds but not falling within the definition of“highly fluorinated” polymers as discussed above, may also be used. Suchpolymers include co-polymers formed from one or more of the monomers inthe preceding paragraph with ethylene, vinyl fluoride or other monomerto form a polymeric material having a greater number of C—H bonds thanC—F bonds. Other fluorinated polymers, such as fluorinated polyimide,may also be used. Other materials that could be used in someapplications, alone or in combination with a fluorinated or a highlyfluorinated polymer, are described in U.S. Pat. No. 4,985,559 and inU.S. Pat. No. 4,528,311, both of which are hereby incorporated byreference herein in their entirety.

The preceding definition of highly fluorinated is best illustrated bymeans of a few examples. One preferred UV-resistant polymeric materialis polyvinylidene fluoride (PVDF), having a structure represented by theformula: —(CF2-CH2)n-. Each repeating unit has two C—H bonds, and twoC—F bonds. Because the number of C—F bonds equals or exceeds the numberof C—H bonds, PVDF homopolymer is a “highly fluorinated” polymer.Another material is a tetrafluoroethylene/vinyl fluoride copolymerformed from these two monomers in a 2:1 molar ratio. Regardless ofwhether the copolymer formed is block, random or any other arrangement,from the 2:1 tetrafluoroethylene:vinyl fluoride composition one canpresume a “repeating unit” comprising two tetrafluoroethylene units,each having four C—F bonds, and one vinyl fluoride unit having three C—Hbonds and one C—F bond. The total bonds for two tetrafluoroethylenes andone vinyl fluoride are nine C—F bonds, and three C—H bonds. Because thenumber of C—F bonds equals or exceeds the number of C—H bonds, thiscopolymer is considered highly fluorinated.

Certain highly fluorinated polymers, such as PVDF, have one or moredesirable characteristics, such as being relatively chemically inert andhaving a relatively high UV transparency as compared to theirnon-fluorinated or less highly fluorinated counterpart polymers.Although the applicant does not intend to be bound by theory, it ispostulated that the electronegativity of fluorine may be responsible formany of the desirable properties of the materials having relativelylarge numbers of C—F bonds.

In preferred embodiments, at least a portion of the highly fluorinatedpolymer material forming the mask comprises an opacification agent whichimparts a desired degree of opacity. In one embodiment, theopacification agent provides sufficient opacity to produce the depth offield improvements described herein, e.g., in combination with atransmissive aperture. In one embodiment, the opacification agentrenders the material opaque. In another embodiment, the opacificationagent prevents transmission of about 90 percent or more of incidentlight. In another embodiment, the opacification agent renders thematerial opaque. In another embodiment, the opacification agent preventstransmission of about 80 percent or more of incident light. Preferredopacification agents include, but are not limited to organic dyes and/orpigments, preferably black ones, such as azo dyes, hematoxylin black,and Sudan black; inorganic dyes and/or pigments, including metal oxidessuch as iron oxide black and ilminite, silicon carbide and carbon (e.g.carbon black, submicron powdered carbon). The foregoing materials may beused alone or in combination with one or more other materials. Theopacification agent may be applied to one or more surfaces of the maskon all or some of the surface, or it may be mixed or combined with thepolymeric material (e.g. blended during the polymer melt phase).Although any of the foregoing materials may be used, carbon has beenfound to be especially useful in that it does not fade over time as domany organic dyes, and that it also aids the UV stability of thematerial by absorbing UV radiation. In one embodiment, carbon may bemixed with polyvinylidene fluoride (PVDF) or other polymer compositioncomprising highly fluorinated polymer such that the carbon comprisesabout 2% to about 20% by weight of the resulting composition, includingabout 10% to about 15% by weight, including about 12%, about 13%, andabout 14% by weight of the resulting composition.

Some opacification agents, such as pigments, which are added to blacken,darken or opacify portions of the mask may cause the mask to absorbincident radiation to a greater degree than mask material not includingsuch agents. Because the matrix polymer that carries or includes thepigments may be subject to degradation from the absorbed radiation, itis preferred that the mask, which is thin and has a high surface areamaking it vulnerable to environmental degradation, be made of a materialwhich is itself resistant to degradation such as from UV radiation, orthat it be generally transparent to or non-absorbing of UV radiation.Use of a highly UV resistant and degradation resistant material, such asPVDF, which is highly transparent to UV radiation, allows for greaterflexibility in choice of opacification agent because possible damage tothe polymer caused by selection of a particular opacification agent isgreatly reduced.

A number of variations of the foregoing embodiments of degradationresistant constructions are contemplated. In one variation, a mask ismade almost exclusively of a material that is not subject to UVdegradation. For example, the mask can be made of a metal, a highlyfluorinated polymer, carbon (e.g., graphene, pure carbon), or anothersimilar material. Construction of the mask with metal is discussed inmore detail in U.S. application Ser. No. 11/000,562 filed Dec. 1, 2004and entitled “Method of Making an Ocular Implant” and also in U.S.application Ser. No. 11/107,359 filed Apr. 14, 2005 with the title“Method of Making an Ocular Implant”, both of which are incorporatedherein in their entirety by reference. As used in this context,“exclusively” is a broad term that allows for the presence of somenon-functional materials (e.g., impurities) and for an opacificationagent, as discussed above. In other embodiments, the mask can include acombination of materials. For example, in one variation, the mask isformed primarily of any implantable material and is coated with a UVresistant material. In another variation, the mask includes one or moreUV degradation inhibitors and/or one or more UV degradation resistantpolymers in sufficient concentration such that the mask under normal useconditions will maintain sufficient functionality in terms ofdegradation to remain medically effective for at least about 5 years,preferably at least about 10 years, and in certain implementations atleast about 20 years.

FIG. 23 is a flow chart illustrating methods for making a maskedintraocular implant from a mask comprising a highly fluorinated polymerand an opacification agent. The method of FIG. 23 includes a firstmethod 3014 of making a mask of highly fluorinated polymer andopacification agent and a second method 3026 of making an intraocularimplant with the mask made from the first method 3014.

At step 3000, a liquid form of a polymer is created by dissolvingpolyvinylidene fluoride (PVDF) pellets into a solvent such as dimethylacetamide (DMAC or DMA) using heat until the PVDF has completelydissolved. In one embodiment, the solution may be mixed for a minimum of12 hours to ensure that the PVDF has completely dissolved. At step 3200,the PVDF/DMAC solution is mixed with an opacification agent, such as adye or carbon black, using a high speed shear mixer. In one embodiment,the carbon black comprises 13% by weight of the resulting compositionwhile the PVDF comprises 87% by weight of the resulting composition. Atstep 3300, the PVDF/carbon black solution is optionally milled in a highspeed mill, for example an Eiger high speed mill, to break up any largecarbon agglomerates in the solution. The PVDF/carbon black solution maybe run through the mill a second time to further break up any carbonagglomerates. At step 3400, the resulting solution is applied to asilicon wafer to create a polymer film on the silicon disk. Here,approximately 55 g of the PVDF/carbon black solution is poured into adispensing barrel for application on a silicon wafer. The silicon diskis placed on the spinner of a spin casting machine and the dispensingbarrel is used to apply a bead of PVDF/carbon black solution to thesilicon wafer in a circular pattern, leaving the center 1″ diameter ofthe disk empty. The spinner cycle is actuated to disperse thePVDF/carbon black solution over the disk, forming a uniform 10 micronthick film. A polymer film may also be deposited, spray coated, etc. toa silicon wafer. The coated silicon disk is then placed on a hot-plateto evaporate the DMAC. At step 3500, the coated silicon wafer is placedunder an excimer laser. A laser cutting mask is mounted in the laser andthe laser is actuated. Using the laser cutting mask, approximately 150mask patterns are laser machined into the PVDF/carbon black film. Themask patterns may also be formed using a punch technique, electron beam,etch, etc. The mask patterns are arranged such that the materialextending approximately 5 mm from the edge of the silicon disk is notused. During the laser machining, the silicon disk may be bathed innitrogen gas in order to cool the surface. At step 3600, the lasermachined masks are removed from the silicon disk using a razor blade. Anoptional step may include placing the laser-machined mask into a formingmold. The mold can be any shape desired, such as a flat mold, a convexmold, a concave mold, or a mold with a more complex shape. The mask maybe placed in the bottom half of the forming mold in one technique. Thetop half of the forming mold can be placed on top of the mask and themolds can be placed in an oven at about 160° C. The molds are thenheated and baked to form the masks. The molds are allowed to bake forapproximately two hours at approximately 160° C. After two hours theoven temperature is reduced to about 30° C. and the masks are baked forapproximately two hours or until the oven temperature has dropped tobelow around 40° C.

At step 3016, the inlay (e.g. mask) made in the first method 3014 isplaced in a mold form. In one embodiment, silicone or other lensmaterial is injected into the mold form and around the inlay. At step3018, the silicone is cured to form an implant body. At step 3020, theintraocular implant is polished, and at step 3022, the implant body isextracted from the mold form. At step 3024, one or more haptics may beattached (e.g. bonded) to the implant body to form an intraocularimplant. Step 3024 may be included for a three piece IOL design, but maynot be needed for other designs. In certain embodiments, the one or morehaptics are formed with the implant body during the injection process.For example, the implant body may be lathed and the haptics milled froma single piece. The intraocular implant can be subsequently inspected(e.g. cosmetic, diopter, resolution).

IV. Masks Configured to Reduce Visible Diffraction Patterns

Many of the foregoing masks can be used to improve the depth of focus ofa patient. Various additional mask embodiments are discussed below. Someof the embodiments described below include light transmission holesthrough the mask annular region to change the amount of light blocked bythe annular region. Light transmission holes through the mask canimprove a patient's dim or low light vision. In certain arrangements oflight transmission holes, the light transmission holes may generatediffraction patterns that interfere with the vision improving effect ofthe masks described herein. Accordingly, certain masks are describedherein that include light transmission holes that do not generatediffraction patterns or otherwise interfere with the vision enhancingeffects of the mask embodiments.

FIGS. 18-19 show one embodiment of a mask 2100 configured to increasedepth of focus of an eye of a patient with presbyopia. The mask 2100 issimilar to the masks hereinbefore described, except as describeddifferently below. The mask 2100 can be made of the materials discussedherein, including those discussed above. Also, the mask 2100 can beformed by any suitable process. The mask 2100 is configured to beapplied to an IOL.

In one embodiment, the mask 2100 includes a body 2104 that has ananterior surface 2108 and a posterior surface 2112. The body 2104 may beformed of any suitable material, including at least one of an open cellfoam material, an expanded solid material, and a substantially opaquematerial. In one embodiment, the material used to form the body 2104 hasrelatively high water content. In other embodiments, the materials thatcan be used to form the body 2104 include polymers (e.g. PMMA, PVDF,polypropylene, polycarbonate, PEEK, polyethylene, acrylic copolymers(e.g., hydrophobic or hydrophilic), polystyrene, PVC, polysulfone),hydrogels, silicone, metals, metal alloys, or carbon (e.g., graphene,pure carbon).

In one embodiment, the mask 2100 includes a light transmission holearrangement 2116. The light transmission hole arrangement 2116 maycomprise a plurality of holes 2120. The holes 2120 are shown on only aportion of the mask 2100, but the holes 2120 preferably are locatedthroughout the body 2104 in one embodiment. In one embodiment, the holes2120 are arranged in a hex pattern, which is illustrated by a pluralityof locations 2120′ in FIG. 20A. As discussed below, a plurality oflocations may be defined and later used in the later formation of aplurality of holes 2120 on the mask 2100. The mask 2100 has an outerperiphery 2124 that defines an outer edge of the body 2104. In someembodiments, the mask 2100 includes an aperture 2128 at least partiallysurrounded by the outer periphery 2124 and a non-transmissive portion2132 located between the outer periphery 2124 and the aperture 2128.

Preferably the mask 2100 is symmetrical, e.g., symmetrical about a maskaxis 2136. In one embodiment, the outer periphery 2124 of the mask 2100is circular. The mask in general has a diameter within the range of fromabout 3 mm to about 8 mm, often within the range of from about 3.5 mm toabout 6 mm, and less than about 6 mm in one embodiment. In anotherembodiment, the mask is circular and has a diameter in the range of 4 to6 mm. In another embodiment, the mask 2100 is circular and has adiameter of less than 4 mm. The outer periphery 2124 has a diameter ofabout 3.8 mm in another embodiment. In some embodiments, masks that areasymmetrical or that are not symmetrical about a mask axis providebenefits, such as enabling a mask to be located or maintained in aselected position with respect to the anatomy of the eye.

The body 2104 of the mask 2100 may be configured to be coupled with aparticular intraocular lens design, either of reduced thickness designor of conventional design. For example, where the mask 2100 is to becoupled with a particular IOL that has curvature, the body 2104 may beprovided with a corresponding amount of curvature along the mask axis2136 that corresponds to the curvature. Likewise, the body 2104 may beprovided with corresponding shape to accommodate IOL transition zones.

In some embodiments, the mask 2100 has a desired amount of opticalpower. Optical power may be provided by configuring the at least one ofthe anterior and posterior surfaces 2108, 2112 with curvature. In oneembodiment, the anterior and posterior surfaces 2108, 2112 are providedwith different amounts of curvature. In this embodiment, the mask 2100has varying thickness from the outer periphery 2124 to the aperture2128.

In one embodiment, one of the anterior surface 2108 and the posteriorsurface 2112 of the body 2104 is substantially planar. In one planarembodiment, very little or no uniform curvature can be measured acrossthe planar surface. In another embodiment, both of the anterior andposterior surfaces 2108, 2112 are substantially planar. In general, thethickness of the body 2104 of the mask 2100 may be within the range offrom greater than zero to about 0.5 mm. In another embodiment, thethickness 2138 of the mask 2100 is about 0.25 mm. [0201] A substantiallyplanar mask has several advantages over a non-planar mask. For example,a substantially planar mask can be fabricated more easily than one thathas to be formed to a particular curvature. In particular, the processsteps involved in inducing curvature in the mask 2100 can be eliminated.

The aperture 2128 is configured to transmit substantially all incidentlight along the mask axis 2136. The non-transmissive portion 2132surrounds at least a portion of the aperture 2128 and substantiallyprevents transmission of incident light thereon. As discussed inconnection with the above masks, the aperture 2128 may be a through-holein the body 2104 or a substantially light transmissive (e.g.,transparent) portion thereof. The aperture 2128 of the mask 2100generally is defined within the outer periphery 2124 of the mask 2100.The aperture 2128 may take any of suitable configurations, such as thosedescribed above.

In one embodiment, the aperture 2128 is substantially circular and issubstantially centered in the mask 2100. The size of the aperture 2128may be any size that is effective to increase the depth of focus of aneye of a patient suffering from presbyopia. In particular, the size ofthe aperture 2128 is dependent on the location of the mask within theeye (e.g., distance from the retina). For example, in the intraocularspace of the eye, the aperture 2128 can be circular, having a diameterof less than about 2 mm in one embodiment. In another embodiment, thediameter of the aperture is between about 1.1 mm and about 1.6 mm. Inanother embodiment, the aperture 2128 is circular and has a diameter ofabout 1.6 mm or less. In a further embodiment, the diameter of theaperture is about mm. Most apertures will have a diameter within therange of from about 0.85 mm to about 2.2 mm, and often within the rangeof from about 1.1 mm to about 1.7 mm.

In certain embodiments, the aperture 2128 includes an optical powerand/or refractive properties. For example, the aperture 2128 can includean optic and can have an optical power (e.g. positive or negativeoptical power). In certain embodiments, the aperture 2128 can correctfor refractive errors of an eye.

The non-transmissive portion 2132 is configured to prevent transmissionof radiant energy through the mask 2100. For example, in one embodiment,the non-transmissive portion 2132 prevents transmission of substantiallyall of at least a portion of the spectrum of the incident radiantenergy. In one embodiment, the non-transmissive portion 2132 isconfigured to prevent transmission of substantially all visible light,e.g., radiant energy in the electromagnetic spectrum that is visible tothe human eye. The non-transmissive portion 2132 may substantiallyprevent transmission of radiant energy outside the range visible tohumans in some embodiments.

As discussed above, preventing transmission of light through thenon-transmissive portion 2132 decreases the amount of light that reachesthe retina and the fovea that would not converge at the retina and foveato form a sharp image. As discussed above, the size of the aperture 2128is such that the light transmitted therethrough generally converges atthe retina or fovea. Accordingly, a much sharper image is presented tothe eye than would otherwise be the case without the mask 2100.

In one embodiment, the non-transmissive portion 2132 preventstransmission of at least about 90 percent of incident light. In anotherembodiment, the non-transmissive portion 2132 prevents transmission ofat least about 95 percent of all incident light. The non-transmissiveportion 2132 of the mask 2100 may be configured to be substantiallyopaque to prevent the transmission of light. As used herein the term“opaque” is intended to indicate a transmission of no more than about 2%of incident visible light. In one embodiment, at least a portion of thebody 2104 is configured to be opaque to more than 99 percent of thelight incident thereon.

As discussed above, the non-transmissive portion 2132 may be configuredto prevent transmission of light without absorbing the incident light.For example, the mask 2100 could be made reflective or could be made tointeract with the light in a more complex manner, as discussed in U.S.Pat. No. 6,554,424, issued Apr. 29, 2003, which is hereby incorporatedby reference herein in its entirety.

As discussed above, the mask 2100 also has light transmission holes thatin some embodiments comprises the plurality of holes 2120. The presenceof the plurality of holes 2120 (or other light transmission structures)may affect the transmission of light through the non-transmissiveportion 2132 by potentially allowing more light to pass through the mask2100. In one embodiment, the non-transmissive portion 2132 is configuredto absorb about 98 percent or more of the incident light from passingthrough the mask 2100 without holes 2120 being present. The presence ofthe plurality of holes 2120 allows more light to pass through thenon-transmissive portion 2132 such that only about 95 percent of thelight incident on the non-transmissive portion 2132 is prevented frompassing through the non-transmissive portion 2132. The holes 2120 mayreduce the benefit of the aperture 2128 on the depth of focus of the eyeby allowing more light to pass through the non-transmissive portion tothe retina.

As discussed above, the holes 2120 of the mask 2100 shown in FIG. 18Amay be located anywhere on the mask 2100. Other mask embodimentsdescribed herein below locate substantially all of the lighttransmission holes are in one or more regions of a mask.

The holes 2120 of FIG. 18A extend at least partially between theanterior surface 2108 and the posterior surface 2112 of the mask 2100.In one embodiment, each of the holes 2120 includes a hole entrance 2160and a hole exit 2164. The hole entrance 2160 is located adjacent to theanterior surface 2108 of the mask 2100. The hole exit 2164 is locatedadjacent to the posterior surface 2112 of the mask 2100. In oneembodiment, each of the holes 2120 extends the entire distance betweenthe anterior surface 2108 and the posterior surface 2112 of the mask2100.

In one embodiment, the holes 2120 have a diameter in the range of about0.002 mm to about 0.050 mm. In certain embodiments, the holes 2120 havea diameter of about 0.005 mm or more. In another embodiment, the holeshave a diameter of about 0.020 mm. In another embodiment, the holes havea diameter of about 0.025 mm. In another embodiment, the holes have adiameter of about 0.027 mm. In another embodiment, the holes 2120 have adiameter in the range of about 0.020 mm to about 0.029 mm. In oneembodiment, the number of holes in the plurality of holes 2120 isselected such that the sum of the surface areas of the hole entrances2140 of all the holes 2100 comprises about 5 percent or more of surfacearea of the anterior surface 2108 of the mask 2100. In anotherembodiment, the number of holes 2120 is selected such that the sum ofthe surface areas of the hole exits 2164 of all the holes 2120 comprisesabout 5 percent or more of surface area of the posterior surface 2112 ofthe mask 2100. In another embodiment, the number of holes 2120 isselected such that the sum of the surface areas of the hole exits 2164of all the holes 2120 comprises about 5 percent or more of surface areaof the posterior surface 2112 of the mask 2112 and the sum of thesurface areas of the hole entrances 2140 of all the holes 2120 comprisesabout 5 percent or more of surface area of the anterior surface 2108 ofthe mask 2100. In another embodiment, the plurality of holes 2120 maycomprise about 1600 microperforations. In another embodiment, theplurality of holes 2120 comprises about 8400 microperforations.

Each of the holes 2120 may have a relatively constant cross-sectionalarea. In one embodiment, the cross-sectional shape of each of the holes2120 is substantially circular. Each of the holes 2120 may comprise acylinder extending between the anterior surface 2108 and the posteriorsurface 2112.

The relative position of the holes 2120 is of interest in someembodiments. As discussed above, the holes 2120 of the mask 2100 arehex-packed, e.g., arranged in a hex pattern. In particular, in thisembodiment, each of the holes 2120 is separated from the adjacent holes2120 by a substantially constant distance, sometimes referred to hereinas a hole pitch. In one embodiment, the hole pitch is about 0.045 mm.

In a hex pattern, the angles between lines of symmetry are approximately43 degrees. The spacing between any two neighboring holes is generallywithin the range of from about 30 microns to about 100 microns, and, inone embodiment, is approximately 43 microns. The hole diameter isgenerally within the range of from about 2 microns to about 100 microns,and in one embodiment, is approximately 20 microns. The lighttransmission is a function of the sum of hole areas as will beunderstood by those of skill in the art in view of the disclosureherein.

Negative visual effects may arise due to the presence of the lighttransmission hole arrangement 2116. For example, in some cases, a hexpacked arrangement of the holes 2120 can generate diffraction patternsvisible to the patient. For example, patients might observe a pluralityof spots, e.g., six spots, surrounding a central light with holes 2120having a hex patterned.

A variety of techniques are possible that produce advantageousarrangements of light transmission holes such that diffraction patternsand other deleterious visual effects do not substantially inhibit othervisual benefits of a mask. In one embodiment, where diffraction effectswould be observable, the light transmission holes are arranged to spreadthe diffracted light out uniformly across the image to eliminateobservable spots. In another embodiment, the light transmission holesemploy a pattern that substantially eliminates diffraction patterns orpushes the patterns to the periphery of the image.

FIGS. 20B-20C show two embodiments of patterns of holes 2220′ that maybe applied to a mask that is otherwise substantially similar to the mask2100. The holes 2220′ of the hole patterns of FIGS. 20B-20C are spacedfrom each other by a random hole spacing or hole pitch. In otherembodiments discussed below, holes are spaced from each other by anon-uniform amount, not a random amount. In one embodiment, the holes2220′ have a substantially uniform shape (cylindrical shafts having asubstantially constant cross-sectional area). FIG. 20C illustrates aplurality of holes 2220′ separated by a random spacing, wherein thedensity of the holes is greater than that of FIG. 20B. Generally, thehigher the percentage of the mask body that has holes the more the maskwill allow light to transmit through the mask. One way to provide ahigher percentage of hole area is to increase the density of the holes.Increased hole density can also permit smaller holes to achieve the samelight transmission as is achieved by less dense, larger holes.

FIG. 21A shows a portion of another mask 2200 a that is substantiallysimilar to the mask 2100, except described differently below. The mask2200 a can be made of the materials discussed herein, including thosediscussed above. The mask 2200 a can be formed by any suitable process,such as those discussed herein and with variations of such processes.The mask 2200 a has a light transmission hole arrangement 2216 a thatincludes a plurality of holes 2220 a. A substantial number of the holes2220 a have a non-uniform size. The holes 2220 a may be uniform incross-sectional shape. The cross-sectional shape of the holes 2220 a issubstantially circular in one embodiment. The holes 2220 a may becircular in shape and have the same diameter from a hole entrance to ahole exit, but are otherwise non-uniform in at least one aspect, e.g.,in size. It may be preferable to vary the size of a substantial numberof the holes by a random amount. In another embodiment, the holes 2220 aare non-uniform (e.g., random) in size and are separated by anon-uniform (e.g., a random) spacing.

FIG. 21B illustrates another embodiment of a mask 2200 b that issubstantially similar to the mask 2100, except as described differentlybelow. The mask 2200 b can be made of the materials discussed herein.Also, the mask 2200 b can be formed by any suitable process, such asthose discussed herein and with variations of such processes. The mask2200 b includes a body 2204 b. The mask 2200 b has a light transmissionhole arrangement 2216 b that includes a plurality of holes 2220 b with anon-uniform facet orientation. In particular, each of the holes 2220 bhas a hole entrance that may be located at an anterior surface of themask 2200 b. A facet of the hole entrance is defined by a portion of thebody 2204 b of the mask 2200 b surrounding the hole entrance. The facetis the shape of the hole entrance at the anterior surface. In oneembodiment, most or all the facets have an elongate shape, e.g., anoblong shape, with a long axis and a short axis that is perpendicular tothe long axis. The facets may be substantially uniform in shape. In oneembodiment, the orientation of facets is not uniform. For example, asubstantial number of the facets may have a non-uniform orientation. Inone arrangement, a substantial number of the facets have a randomorientation. In some embodiments, the facets are non-uniform (e.g.,random) in shape and are non-uniform (e.g., random) in orientation.

Other embodiments may be provided that vary at least one aspect,including one or more of the foregoing aspects, of a plurality of holesto reduce the tendency of the holes to produce visible diffractionpatterns or patterns that otherwise reduce the vision improvement thatmay be provided by a mask with an aperture, such as any of thosedescribed above. For example, in one embodiment, the hole size, shape,and orientation of at least a substantial number of the holes may bevaried randomly or may be otherwise non-uniform. The mask may also becharacterized in that at least one of the hole size, shape, orientation,and spacing of a plurality of holes is varied to reduce the tendency ofthe holes to produce visible diffraction patterns. In certainembodiments, the tendency of the holes to produce visible diffractionpatterns is reduced by having a plurality of the holes having a firsthole size, shape, or spacing and at least another plurality of the holeswith a second hole size, shape, or spacing different from the first holesize, shape, or spacing. In other embodiments, the mask is characterizedin that at least one of the hole size, shape, orientation, and spacingof a substantial number of the plurality of holes is different than atleast one of the hole size, shape, orientation, and spacing of at leastanother substantial number of the plurality of holes to reduce thetendency of the holes to produce visible diffraction patterns. Infurther embodiments, the holes are positioned at irregular locations.For example, the holes are positioned at irregular locations to minimizethe generation of visible artifacts due to the transmission of lightthrough the holes.

FIG. 22 shows another embodiment of a mask 2300 that is substantiallysimilar to any of the masks hereinbefore described, except as describeddifferently below. The mask 2300 can be made of the materials discussedherein. Also, the mask 2300 can be formed by any suitable process, suchas those discussed herein and with variations of such processes. Themask 2300 includes a body 2304. The body 2304 has an outer peripheralregion 2305, an inner peripheral region 2306, and a hole region 2307.The hole region 2307 is located between the outer peripheral region 2305and the inner peripheral region 2306. The body 2304 may also include anaperture region 2328, where the aperture (discussed below) is not athrough hole. The mask 2300 also includes a light transmission holearrangement 2316. In one embodiment, the light transmission holearrangement includes a plurality of holes. At least a substantialportion of the holes (e.g., all of the holes) are located in the holeregion 2307. As above, only a portion of the light transmission holearrangement 2316 is shown for simplicity. But it should be understoodthat the hole arrangement may be located throughout the hole region2307.

The outer peripheral region 2305 may extend from an outer periphery 2324of the mask 2300 to a selected outer circumference 2325 of the mask2300. The selected outer circumference 2325 of the mask 2300 is locateda selected radial distance from the outer periphery 2324 of the mask2300. In one embodiment, the selected outer circumference 2325 of themask 2300 is located about 0.05 mm from the outer periphery 2324 of themask 2300.

The inner peripheral region 2306 may extend from an inner location,e.g., an inner periphery 2326 adjacent an aperture 2328 of the mask 2300to a selected inner circumference 2327 of the mask 2300. The selectedinner circumference 2327 of the mask 2300 is located a selected radialdistance from the inner periphery 2326 of the mask 2300. In oneembodiment, the selected inner circumference 2327 of the mask 2300 islocated about 0.05 mm from the inner periphery 2326.

The mask 2300 may be the product of a process that involves randomselection of a plurality of locations and formation of holes on the mask2300 corresponding to the locations. As discussed further below, themethod can also involve determining whether the selected locationssatisfy one or more criteria. For example, one criterion prohibits all,at least a majority, or at least a substantial portion of the holes frombeing formed at locations that correspond to the inner or outerperipheral regions 2305, 2306. Another criterion prohibits all, at leasta majority, or at least a substantial portion of the holes from beingformed too close to each other. For example, such a criterion could beused to assure that a wall thickness, e.g., the shortest distancebetween adjacent holes, is not less than a predetermined amount. In oneembodiment, the wall thickness is prevented from being less than about20 microns.

In a variation of the embodiment of FIG. 22, the outer peripheral region2305 is eliminated and the hole region 2307 extends from the innerperipheral region 2306 to an outer periphery 2324. In another variationof the embodiment of FIG. 50, the inner peripheral region 2306 iseliminated and the hole region 2307 extends from the outer peripheralregion 2305 to an inner periphery 2326.

In any of the foregoing mask embodiments, the body of the mask may beformed of a material selected to substantially prevent negative opticeffects, such as diffraction, as discussed above. In variousembodiments, the masks are formed of an open cell foam material,silicone, thermoset and thermoeleastic polymers such as PVDF, PMMA,metal, Teflon, or carbon. In another embodiment, the masks are formed ofan expanded solid material.

As discussed above in connection with FIGS. 20B and 20C, various randompatterns of holes may advantageously be provided. In some embodiments,it may be sufficient to provide regular patterns that are non-uniform insome aspect. Non-uniform aspects to the holes may be provided by anysuitable technique.

In a first step of one technique, a plurality of locations 2220′ isgenerated. The locations 2220′ are a series of coordinates that maycomprise a non-uniform pattern or a regular pattern. The locations 2220′may be randomly generated or may be related by a mathematicalrelationship (e.g., separated by a fixed spacing or by an amount thatcan be mathematically defined). In one embodiment, the locations areselected to be separated by a constant pitch or spacing and may be hexpacked.

In a second step, a subset of the locations among the plurality oflocations 2220′ is modified to maintain a performance characteristic ofthe mask. The performance characteristic may be any performancecharacteristic of the mask. For example, the performance characteristicmay relate to the structural integrity of the mask. Where the pluralityof locations 2220′ is selected at random, the process of modifying thesubset of locations may make the resulting pattern of holes in the maska “pseudo-random” pattern.

Where a hex packed pattern of locations (such as the locations 2120′ ofFIG. 20A) is selected in the first step, the subset of locations may bemoved with respect to their initial positions as selected in the firststep. In one embodiment, each of the locations in the subset oflocations is moved by an amount equal to a fraction of the hole spacing.For example, each of the locations in the subset of locations may bemoved by an amount equal to one-quarter of the hole spacing. Where thesubset of locations is moved by a constant amount, the locations thatare moved preferably are randomly or pseudo-randomly selected. Inanother embodiment, the subset of location is moved by a random or apseudo-random amount.

In certain embodiments, an outer peripheral region is defined thatextends between the outer periphery of the mask and a selected radialdistance of about 0.05 mm from the outer periphery. In anotherembodiment, an inner peripheral region is defined that extends betweenan aperture of the mask and a selected radial distance of about 0.05 mmfrom the aperture. In another embodiment, an outer peripheral region isdefined that extends between the outer periphery of the mask and aselected radial distance and an inner peripheral region is defined thatextends between the aperture of the mask and a selected radial distancefrom the aperture. In one technique, the subset of location is modifiedby excluding those locations that would correspond to holes formed inthe inner peripheral region or the outer peripheral region. By excludinglocations in at least one of the outer peripheral region and the innerperipheral region, the strength of the mask in these regions isincreased. Several benefits are provided by stronger inner and outerperipheral regions. For example, the mask may be easier to handle duringmanufacturing or when being rolled without causing damage to the mask.In other embodiments, the mask does not include an outer peripheralregion and/or inner peripheral region that do not have holes (e.g.,holes may extend to the inner periphery and/or the outer periphery).

In another embodiment, the subset of locations is modified by comparingthe separation of the holes with minimum and or maximum limits. Forexample, it may be desirable to assure that no two locations are closerthan a minimum value. In some embodiments this is important to assurethat the wall thickness, which corresponds to the separation betweenadjacent holes, is no less than a minimum amount. As discussed above,the minimum value of separation is about 20 microns in one embodiment,thereby providing a wall thickness of no less than about 20 microns.

In another embodiment, the subset of locations is modified and/or thepattern of location is augmented to maintain an optical characteristicof the mask. For example, the optical characteristic may be opacity andthe subset of locations may be modified to maintain the opacity of anon-transmissive portion of a mask. In another embodiment, the subset oflocations may be modified by equalizing the density of holes in a firstregion of the body compared with the density of holes in a second regionof the body. For example, the locations corresponding to the first andsecond regions of the non-transmissive portion of the mask may beidentified. In one embodiment, the first region and the second regionare arcuate regions (e.g., wedges) of substantially equal area. A firstareal density of locations (e.g., locations per square inch) iscalculated for the locations corresponding to the first region and asecond areal density of locations is calculated for the locationscorresponding to the second region. In one embodiment, at least onelocation is added to either the first or the second region based on thecomparison of the first and second areal densities. In anotherembodiment, at least one location is removed based on the comparison ofthe first and second areal densities.

In a third step, a hole is formed in a body of a mask at locationscorresponding to the pattern of locations as modified, augmented, ormodified and augmented. The holes are configured to allow at least somelight transmission through the mask without producing visiblediffraction patterns.

V. Additional Mask Configurations

A mask can have a variety of other configurations includingconfigurations that include features described above. For example, thedensity of light transmission holes (e.g. area of holes per area ofmask) can be different in different areas of the mask. In certainembodiments, the density of holes increases radially out from the innerperiphery to the outer periphery of the mask. In certain otherembodiments, the density of holes decreases radially out from the innerperiphery to the outer periphery of the mask. Other variations are alsopossible. For example, a center annular region of the mask 4000 can havea higher density of holes than an inner annular region and an outerannular region, as illustrated in FIG. 24A. In another example, thecenter annular region of a mask has a lower density of holes than aninner annular region and an outer annular region. The density of holesis the percentage of surface area of the mask that has holes. A densityof holes can be created by, for example, relatively few holes withrelatively large area or relatively many holes with relatively smallarea. As described above, the holes can be arranged to reduce visiblediffraction patterns.

The embodiment of the mask 4000 illustrated in FIG. 24A has an irregularhole pattern as described in Section IV. The mask 4000 includes an innerperipheral region neighboring the inner periphery of the mask 4000, anouter peripheral region neighboring the outer periphery of the mask4000, and ten annular bands between the inner periphery region and theouter periphery region. The first band of the ten annular bandsneighbors the inner periphery region, the second band neighbors thefirst band, and so forth. The tenth band neighbors the outer peripheryregion. Each band includes 840 holes, and the inner periphery region andouter periphery region includes no holes and are 50 microns wide. Eachof the bands has a band width, a percentage of light transmissionthrough the band, and a hole diameter for the holes in the band, asillustrated in Table III. The holes in the ten bands provide an averagelight transmission of 5%. The number and the properties of the bands andthe number and properties of the holes in each band can be varied. Forexample, the bands can be configured to create a light transmissionprofile as described above. In certain embodiments, the mask 4000 has noinner periphery region and/or outer periphery region.

TABLE III Properties of the example mask illustrated in FIG. 24A. HoleDiameter Band Width Band No. (microns) % Transmission (microns) 1 5.452.3 146 2 7.45 4.3 127 3 9.45 6.9 114 4 11.45 10.2 105 5 10.45 8.5 97 69.45 6.9 91 7 8.45 5.6 86 8 7.45 4.3 81 9 6.45 3.2 78 10 5.45 2.3 74

The transition of the density of holes between the center annular regionto the inner and/or outer annular regions can be a gradual radialtransition or can be a transition with one or more steps. The change inthe density of holes from one region to another can be done by havingthe number of holes remain constant while the hole size is varied, byhaving the hole size remain constant while the number of holes isvaried, or a combination of varying the number of holes and the holesize. Additional details regarding transition of the density of holesbetween the center annular region to the inner and/or outer annularregions are described in the concurrently filed international patentapplication, the entirety of which is hereby incorporated by reference,titled “CORNEAL INLAY WITH NUTRIENT TRANSPORT STRUCTURES,” InternationalPatent Application No. TBD (Attorney Docket No. ACUFO.123VPC) filed thesame day as the present application, which claims the benefit of U.S.Provisional Application No. 61/233,802, by Bruce Christie, Edward W.Peterson, and Corina van de Pol.

Advantageously, by having at least some light transmission through themask, patient dim light vision can be improved over having substantiallyno light transmission through the mask. Embodiments include total areadensity of holes of the mask of greater than 1%, less than 10%, between1% and 10%, between 2% and 5%. Embodiments include light transmittancethrough the mask of greater than 1%, less than 10%, between 1% and 10%,between 2% and 5%. In certain embodiments, the center annular region ofthe mask has an average light transmittance of between 2% and 5% and theinner annular region and the outer annular region have an average lighttransmittance of between 1 and 2%. In certain embodiments, the innerannular region is the annular region between the inner periphery of themask to about one-third the radial distance from the inner periphery tothe outer periphery of the mask. In certain embodiments, the outerannular region is the annular region between the outer periphery of themask to about one-third the radial distance from the outer periphery tothe inner periphery of the mask. In certain embodiments, the centerannular region is the annular region between the inner annular regionand the outer annular region.

Advantageously, if the mask is in a position between the posterior andanterior surfaces of a lens body, the holes through the mask can help toprevent delamination of the interface between the mask and the lensbody. Delamination can occur during manipulation of the intraocularimplant such as when the intraocular implant is folded or rolled andplaced into a tube to be implanted into the patient. The lens body canextend through the holes, thereby creating a bond (e.g. material“bridge”) between the lens body on either side of the mask. Delaminationcan also be reduced by matching mechanical properties (e.g. elasticmodulus) of the mask to the lens body. Another method to reducedelamination is to create a bond between the lens body and the mask. Forexample, the lens body and the mask can have cross-linking bonds or vander Waals forces between them.

The holes in the mask serve at least two purposes: the holes providesome light transmission and the holes create areas where the material ofthe implant body can extend through to create a material “bridge” thatholds the mask in place. In certain embodiments, the mask includes holesgreater than about 7 microns in diameter (e.g., greater than across-sectional area of about 35 μm²), and preferably greater than about10 microns in diameter (e.g., greater than a cross-sectional area ofabout 75 μm²). In certain embodiments, the mask includes holes greaterthan about 7 microns in diameter (e.g., greater than a cross-sectionalarea of about 35 μm²) and less than about 20 microns in diameter (e.g.,less than a cross-sectional area of about 320 μm²). In furtherembodiments, the mask includes holes less than about 50 microns indiameter (e.g., less than a cross-sectional area of about 2000 μm².Holes with diameters less than 7 microns may not be large enough forlens material such as silicone or acrylic to enter and migrate to form abridge. Although, the viscosity of the lens material will affect whetherthe material will be able to migrate into the hole to form the bridgeand a minimum cross-sectional area of the hole may be dependent on thematerial of the implant body. If the material of the implant body doesnot migrate into a hole, that hole may create a bubble that couldinterfere with the visual performance of the implant.

The total amount of light that passes through the mask can be desirableto be minimized to maximize near image contrast. Delamination can beprevented with a relatively small total area of the mask having holesfor “bridges”. For example, an area of about 3% of the mask can includeholes which can balance maximizing mechanical strength and minimizingoptical effects of the holes. In certain embodiments, the anteriorsurface of the mask has a mask surface area, and the light transmissionstructures (e.g., holes) in the mask have a total area on the anteriorsurface of the mask of about 1% to about 5% of the mask surface area. Tolimit the impact of diffraction of light passing through the holes ofthe mask, the holes can be made as small as possible. The Airy disc fromeach hole is larger the smaller the hole size, so the compositediffraction pattern produced by the pattern of holes becomes larger aswell. The composite diffraction pattern spreads light over a largerportion of the retina, decreasing the local brightness of diffractedlight and making diffraction artifacts less visible. Diffractionpatterns produced by a pattern of holes also tends to have a chromaticcomponent such that the diffraction halo tends to graduate in colorradially. Varying the size of the holes produces this effect in multiplescales, which scrambles the color of the halo. This reduces colorcontrast in the halo, making it less noticeable.

In a certain embodiment, the mask includes randomly or pseudo-randomlyplaced holes across the mask. The mask 4100 illustrated in FIG. 24B hasa light transmission of about 3.02%. The mask of FIG. 24B has holes withone of four hole diameters including 10 microns, 13 microns, 16 microns,and 19 microns. There is an equal number of holes with each holediameter. An algorithm can be used to randomly or pseudo-randomly assignthe variously sized holes to locations across the mask annulus. Therules for the randomization program can include (1) that there be no“collisions” of the holes (e.g., the holes have no contact with eachother), (2) that no holes interfere with the inner and outer peripheraledges of the mask, and (3) that the holes are placed in such a way as tocreate substantial uniform density across the mask annulus. For example,the rules for the randomization program may include one or more of theserules. FIGS. 24C and 24D illustrate additional examples of holepositioning for masks 4200, 4300 using similar parameters as that wereused for the mask of FIG. 24B.

The outer diameter of the outer periphery of the mask can be varied. Incertain embodiments, the outer diameter is selected to selectively allowan amount of light to pass to the retina of the eye. The pupil of theeye changes size in different lighting condition. In low lightsituations, the pupil of the eye enlarges to let more light into theeye. The outer diameter can be selected so that light does not passoutside the outer periphery of the mask in relatively high lightconditions, and so that at least some light can pass outside the outerperiphery of the mask in relatively low light conditions. The pupil sizeof patients often can vary; therefore, the outer diameter of the maskcan be selected for a specific patient pupil size. For example, forpatients with relatively small pupils, dim light may present more of avision issue than for patients with larger pupils. For smaller pupilpatients, a mask with more light transmission and/or a smaller outerdiameter will increase light reaching the retina and improve vision indim light situations. Conversely, for larger pupil patients, less lighttransmission and/or a larger outer diameter mask may improvelow-contrast near vision and block more unfocused light. The masked IOLsof the present application give the surgeon flexibility to prescribe theappropriate combination of masked IOL features for particular patients.

In certain embodiments, the center of the aperture of the mask isoff-center to the center of the lens body. By having an apertureoff-center to the optical center of the lens body, the intraocular lenscan be rotated during the implantation procedure so that the opticalcenter of the patient's eye can be aligned with the center of theaperture. The vision of the patient can be improved by aligning theoptical center of the patient's eye with the aperture center.

VI. Methods of Making Ocular Implants

Intraocular implants (e.g., intraocular lenses) can be made or producedin a number of different ways. In certain embodiments, a rod can beformed with an optically transparent inner region along a length of therod, an optically transparent outer region along the length of the rodand a substantially optically non-transparent middle region along thelength of the rod between the inner region and the outer region.Cross-sectional sections along a plane substantially perpendicular to anaxis parallel to the length of the rod can be sectioned out to form animplant body (e.g., lens body) with a mask through the implant body. Incertain embodiments, a rod can be formed by forming an opticallytransparent rod. An opaque cylinder can be formed around the opticallytransparent rod. An optically transparent cylinder can then be formedaround the opaque cylinder. In certain embodiments, the cylinders areformed by casting or molding.

In alternative embodiments, an implant body can be formed and then amask can be attached to the posterior surface and/or anterior surface ofthe implant body. For example, the mask can be adhered with adhesive(e.g. glued), mechanically attached, snapped on, welded (e.g. tackwelding, area welding), taped, press fit, thermal or hydration swellfit, held by surface tension, electric charge, magnetic attraction,polymerization, in-situ cross-linking (e.g. cross-linked by radiation),chemical means, etc. FIG. 25A illustrates an embodiment of anintraocular implant 8000 with a mask 8002 coupled to the anteriorsurface of the implant body 8004, and FIG. 25B illustrates anotherembodiment of an intraocular implant 8010 with a mask 8012 coupled tothe posterior surface of the implant body 8014.

In certain embodiments, the implant body includes a structure to allow amask to securely attach thereto. For example, the implant body caninclude clips or other structures to physically attach the mask. Theimplant body can include a recessed portion on the posterior or anteriorsurface. A mask that substantially fills the recessed portion can beplaced in the recessed portion of the implant body. The inner peripheryand/or the outer periphery of the recessed portion can include one ormore protrusions. The inner periphery and/or the outer periphery caninclude one or more recesses. The mask can be attached to the implantbody by inserting the mask into the recessed portion and the one or moreprotrusions can enter the one or more recesses to prevent the mask fromseparating from the implant body. In certain embodiments, the mask isattached to the implant body after the intraocular implant has beeninserted into the patient. In other embodiments, the mask is attached tothe implant body before the implant body has been inserted into thepatient. For example, the mask can be attached to the implant body in afactory or in an operating room.

In further embodiments, an implant body can be formed around a mask. Forexample, an implant body can be injected molded around a mask. FIG. 25Cillustrates one embodiment of an intraocular implant 8020 with a mask8022 embedded within the implant body 8024. The mask 8032, 8042 can alsobe embedded near the anterior or posterior surface of the implant body8034, 8044 of the intraocular implant 8030, 8040, as illustrated inFIGS. 25D and 25E, respectively. As illustrated in FIG. 25F, the mask8052 can also be positioned near the transition zone 8056 of the implantbody 8054. When the masked is positioned on the transition zone surfaceor within close proximity of the transition zone surface, the mask doesnot necessarily need to extend beyond the transition zone 8056 sincelight even at large angles that hits or passes through the transitionzone surface would be blocked by the mask. The mask 8062 may also extendfrom the anterior surface to the posterior surface of the implant body8064, as illustrated in FIG. 25G. Any of the locations or positions ofthe masks of FIGS. 25A-G can be applied to any of the implant bodies andintraocular implants described herein.

In certain embodiments, the intraocular implant includes one or moresupport members that extend from the mask to an outer surface of theimplant body to aid in manufacturing intraocular implants with masks.The support members can suspend the mask in a mold cavity in desiredalignment in relation to the mold cavity. A contact portion of thesupport member can physically contact a wall of the mold cavity tosupport the mask. For example, the support members can be removablycoupled to mold to keep the mask stationary while the implant body isinjected around the mask but can be removed after the implant body hasbeen formed. The support member can be mechanically coupled to the mask,or the support member and mask can be a single piece (e.g., monolithicstructure).

FIG. 26A illustrates one embodiment of an intraocular implant 8100 witha mask 8104 that is within an implant body 8102. The intraocular implant8100 includes one or more support members 8106 that are coupled to themask 8104 and extend to at least the outer periphery 8106 of the implantbody 8102. The support members 8106 may extend to the surface of theouter periphery 8106 or may extend beyond the surface of the outerperiphery 8106.

FIG. 26B illustrates a second example of an intraocular implant 8110that includes support members 8116. The support members 8116 are coupledto the mask 8114 and extend from the mask 8814 to at least the posteriorsurface 8113 of the implant body 8112. By positioning the supportmembers 8116 between the mask 8114 and the posterior surface 8113, thesupport members 8816 can be hidden from line of sight of a patient.

FIG. 26C illustrates another example of support members 8126 that arehidden from a patient's line of sight. The mask 8124 and the supportmembers 8126 are integrated into a toroid with a triangular or trapezoidcross-sectional shape. The portion of the toroid closer to the anteriorsurface of the implant body 8122 extends radially inwardly and outwardlyfurther than the portion of the toroid closer to the posterior surfaceof the implant body 8122. A cross-section of the mask 8124 and supportmembers 8126 appear as a posteriorly-pointing triangle or as an invertedpyramid. Advantageously, this embodiment minimizes unintended lightblockage.

The support structures may also include tabs that can be removed afterthe implant body has been formed around the mask. FIG. 27A illustratesan embodiment of an intraocular implant 8200 with support structures8202 that include tabs. The support structures 8202 have a first portion8208 that extends from the mask 8204 to a position within the implantbody 8206 with a first cross-sectional area. The support structures 8202also have a second portion 8209 that extends from the first portion tothe surface of the implant body 8206 with a second cross-sectional areathat is greater than the first cross-sectional area. After the implantbody 8206 is formed around the mask 8204, the support structures 8202can be broken off at or near the first portion 8208, as illustrated inFIG. 27B. Removal of the second portion 8209 can leave behind a cavity8207 in the implant body 8206. The cavity 8207 can be left open or canbe filled. For example, if increasing the biocompatibility of theimplant 8200 is desired, the cavities 8207 can be filled so that themask 8204 is physically or biologically isolated from the eye within orby the implant body 8206.

FIG. 28A is a top view and FIG. 28B is a cross-sectional view of anembodiment of an intraocular implant 6700 with a support member 6702.The support member 6702 extends from the mask 6704 to the outerperiphery 6706 of the implant body 6708. The support member 6702 caninclude one or more contact portions 6710 that can removably couple tothe mold during injection of the implant body 6708 around the mask 6704.In certain embodiments, the implant body 6708 is injected around boththe mask 6704 and the support member 6702. The support member 6702 canalso include linking members 6712 that couple the contact portions 6710and the mask 6704. The linking members 6712 have an anterior and/orposterior surface area that is minimized so that the linking member 6712substantially does not block light that passes through the implant body6708 outside the outer periphery of the mask 6704.

The support structure 6702 can include more mass near the outerperiphery of the implant body 6708 where the support structure 6702would less likely interfere with the patient's vision. For example, thesupport structure 6702 can have an annulus or ring near the outerperiphery of the implant body 6708 that provides additional support andfurther restricts movement of the mask 6704 and portions of the supportstructure 6702 during molding process when material flows around themask. The flow of material can produce forces on the mask 6704 andsupport structure 6702. In certain embodiments, the implant body 6708and the haptics 6716 are a single piece (e.g., monolithic structure).

As illustrated in FIG. 28A, the mask 6704, linking members 6712, and/orsupport structure 6702 may include light transmission structures 6720such as holes, as described herein. The mask 6704 may also include aninner peripheral region 6722 neighboring the inner diameter and an outerperipheral region 6724 neighboring the outer diameter that substantiallydoes not have light transmission structures 6720, as described above.The light transmission structures 6720 can be applied to any of theembodiments of described herein and the different configurations oflight transmission structures described herein such as varying holespacing, size, shape and/or orientation can be applied to thisembodiment or any embodiment that includes a mask.

FIG. 29A is a top view and FIG. 29B is a cross-sectional view of anembodiment of an intraocular implant 6800 similar to the intraocularimplant 6700 of FIGS. 28A and 28B with a different optical power. Theintraocular implants features described herein can be combined with avariety of optical power implant bodies.

FIG. 30A is a top view and FIG. 30B is a cross-sectional view of anotherembodiment of an intraocular implant 6900 similar to the intraocularimplant 6700 of FIGS. 28A and 28B. The outer periphery of the mask 6904extends beyond the outer periphery of the transition zone (e.g., secondportion) 6914 which can block light that pass through the transitionzone 6914 at large incident angles (e.g., angle between the normal tothe surface and the incident light) to the anterior surface of theimplant body 6908.

FIGS. 31A-34B are additional embodiments of intraocular implants 7000,7100, 7200, 7300 with various configurations of support members 7002,7102, 7202, 7302. For example, the intraocular implants 7000, 7100 ofFIGS. 31A-32B have support members 7002, 7102 that have linking members7012, 7112 that loop from a first portion of the mask 7004, 7104 to acontact portion 7010, 7110 and back to a second portion of the mask7004, 7104. The intraocular implants 7200, 7300 of FIGS. 33A-34B aresimilar to the intraocular implant 6700 of FIGS. 28A-B; however, thelinking members 7212, 7312 do not connect the mask 7204, 7304 and thecontact portions 7210, 7310 through a straight path. The linking members7212, 7312 connect the mask 7204, 7304 and the contact portions 7210,7310 through a curved or wavy path. The curved or wavy path can reducevisible effects of the linking members 7212, 7312 that a patient mayobserve.

The support members may be integrated with the haptic of intraocularimplant. The haptic and support member may be coupled together or can bea single piece (e.g., monolithic structure). In certain embodiments, themask, support member, and haptic are all coupled together. For example,the mask, support member, and haptic can be a single piece (e.g.,monolithic structure). The mask, support member, and/or haptic maycomprise the same material. Furthermore, the mask, support member,and/or haptic may comprise the same material of the implant body;however, the mask, support member, and/or haptic may include orincorporate a dye or other pigment to create opacity. Alternatively, themask, support member, and/or haptic may comprise different materialsthan the implant body, but be materials that are compatible with thematerial of the implant body. FIG. 35A is a top view and FIG. 35B is across-sectional view of an embodiment of an intraocular implant 7400with a support structure 7402 coupled to a mask 7404 and haptics 7416.The support structure 7402 extends away from the mask 7404 to an outersurface of the implant body 7408. The haptics 7416 extend away from thesupport structure 7402 and implant body 7408. The haptics 7416 canprovide contact portions with the mold to retain the mask 7404 while theimplant body 7408 is injected around the mask 7404. The mask 7404,support structure 7402, and haptics 7416 can be a single piece orcoupled together such that they are configured to resist forces appliedto the mask during formation of the implant body 7408. In certainembodiments, the haptic, support members, and mask may be substantiallyplanar.

FIG. 36A is a top view and FIG. 36B is a cross-sectional view of anembodiment of an intraocular implant 7500 similar to the intraocularimplant 7400 of FIGS. 35A-B. However, the mask 7504 is configured to benear the anterior surface 7518 of the implant body 7508 and follows thecontours of the anterior surface 7518 of the implant body 7508. Thecloser the mask 7504 is to the anterior surface 7518 less light thatpass through the transition zone 7914 on the anterior surface at largeincident angles can pass through the posterior surface 7520 which can beobserved as visible artifacts to a patient. For embodiments where thetransition zone is on the posterior surface, the mask can be positionedto be near the posterior surface. The support member 7502 can alsoconfigured to be near the anterior surface 7518 of the implant body7508.

In certain embodiments, the mask is printed onto an implant body. Themask can be printed on the posterior and/or the anterior surface of theimplant body. The printed mask can either be adjacent the surface of theimplant body or can penetrate into the implant body (stain, tattoo,etc.). Printing options can include offset printing, block printing, jetprinting, etc. The mask can also be applied to the implant body bythermal transfer or hot stamping. The mask may also be laser etched ontothe surface or within the implant body such as with a sub-surface laserengraving. The printed mask can be bonded or adhered to the implantbody. In certain embodiments, the mask is printed onto the implant bodyafter the implant body has been inserted into the patient. In otherembodiments, the mask is printed onto the implant body before theimplant body has been inserted into the patient. For example, the maskcan be printed onto the implant body in a factory or in an operatingroom.

FIGS. 37A-D illustrate another method of forming a mask 8308 on theanterior (or posterior) surface of an implant body 8300 with atransition zone 8304. FIG. 37A illustrates an implant body 8300 withouta transition zone 8304 or mask 8308. A cavity 8302 such as an annuluscan be formed (mechanically, chemically, etc.) into the anterior surfaceof the implant body 8300, as illustrated in FIG. 37B. The cavity 8302can form the transition zone 8304. As illustrated in FIG. 37C, thecavity 8302 can be at least partially filled with an opaque material8306 so that the transition zone 8304 is substantially covered. Thecentral region 8310 can be formed (mechanically, chemically, etc.), asillustrated in FIG. 37D. Some of the opaque material 8306 can also beremoved when the central region 8310 is formed while leaving a layer ofopaque material 8306 substantially covering the transition zone 8304 toform a mask 8308.

FIGS. 38A-E illustrate method of forming a mask 8408 within the implantbody 8400. FIG. 38A illustrates an implant body 8400, and FIG. 38Billustrates the implant body 8400 with a cavity 8402 formed into theanterior surface. A mask 8408 can be positioned within the cavity 8402,as illustrated in FIG. 38C, and the cavity 8402 can be at leastpartially filled with an implant body material 8406 to embed the mask8408 into the implant body 8400, as illustrated in FIG. 38D. FIG. 38Eillustrates the implant body 8400 with a portion the implant bodymaterial removed to form the central region 8410 and the transition zone8404.

FIGS. 39A-D illustrate another method of forming a mask 8508 on theanterior surface of an implant body 8500 with a transition zone 8504.FIG. 39A illustrates an implant body 8500 without a transition zone 8504or mask 8508. A cavity 8502 such as an annulus can be formed into theanterior surface of the implant body 8500, as illustrated in FIG. 39B.As illustrated in FIG. 39C, the cavity 8502 can be at least partiallyfilled with an opaque material 8506. The central region 8510 can beformed, as illustrated in FIG. 39D. Some of the opaque material 8506 canalso be removed when the central region 8510 is formed, and the opaquematerial 8506 can form a transition zone 8504 and a mask 8508.

In certain embodiments, a mask is formed in or on the implant body byselectively making the material of the implant body opaque orreflective. For example, materials such as black silicone,carbon-powdered Teflon, PVDF with carbon, etc. can be used. Additionalexamples of materials that the mask can include are described in U.S.Patent Publication No. 2006/0265058. The implant body can be a materialthat changes from transparent to opaque (e.g., a photochromic material)or reflective upon being exposed to certain conditions. The molecularstructure of the implant body material can be changed optically,chemically, electrically, etc. For example, structure of the implantbody can be changed to create voids, regions of altered index, surfacefacets, etc. In certain embodiments, a dye in or on the implant body canbe activated with light or electricity to change from being transparentto opaque or reflective. In certain embodiments, the mask is formedafter the implant body has been inserted into the patient. In otherembodiments, the mask is formed before the implant body has beeninserted into the patient. For example, the mask can be formed in afactory or in an operating room.

In certain embodiments, the implant body has posterior and/or anteriorsurfaces with contours to create an optical power. The contours of thesurfaces of the implant body can also be formed by a number of methods.For example, the implant body can be molded into a shape. In anotherexample, the surfaces of the implant body can be milled to form thecontours.

Haptics can be formed with the implant body or can be subsequentlyattached to the implant body. For example, haptics can be cast or moldedonto the implant body in a single-piece configuration. In addition,haptics can be mechanically attached to the implant body. For example,holes can be drilled into the implant body and haptics can be inserted.Haptics can also be attached by using an adhesive or glue. In certainembodiments, the intraocular implant does not have an implant body. Ifthe intraocular implant does not have an implant body, the haptics canbe attached to the mask.

There are also a number of methods of positioning and adjusting the maskwithin a mold cavity of a mold. For example, a single mold can be usedwhile the position of a mask within the mold cavity can be adjusted toaccurately position mask relative to the mold cavity and eventually theimplant body. FIG. 40 illustrates an embodiment of a mask positioningsystem 9000 that includes positioning sensors 9010, a mask positioningapparatus 9020, and a control system 9030. The control system 9030 caninclude sensor interface 9032 in electrical communication with afeedback control 9034 that is in electrical communication with a maskpositioning interface 9036. The mask positioning apparatus 9020 canposition the mask 9040 within the implant body 9050.

The positioning sensors 9010 can be used to measure the position of themask within the mold cavity. For example, a Hal Effect sensor can detectmagnetic fields, and the sensor's output voltage can vary in response tochanges in a magnetic field. With a fixed magnetic field, the distanceto the source of the field can be accurately calculated. Diamagneticlevitation and induction levitation are options that can be used with amagnetic mask. Cameras, ultrasonic detectors, capacitive proximitysensors, and laser interferometry can also be used to measure theposition of the mask.

A number of types of mask positioning apparatuses 9020 and methods canbe used to move and position the mask within the mold cavity. Forexample, wires, such as nanowires, can be coupled to the mask and aframe such as a frame that surrounds the mask. FIG. 41 illustrates anembodiment of a mask positioning apparatus 9100 that includes fournanowires 9102 that are coupled to four areas on the mask 9104 at 0, 90,180, and 270 degree positions on the mask 9104 to a surrounding frame9106. The frame 9106 can then be moved to position the mask 9104 with,for example, mechanical actuators and/or servos 9108. Nanowires can beformed by electrodeposition. In certain embodiments, the mask andnanowires are electrodeposited to form a monolithic structure. Since themask can have a low mass, small wires such as nanowires could besufficient to move the mask around within a liquid polymer, and could beeasily broken or sheared off from the implant body after the polymer hassolidified or cured. One advantage of nanowires is that they are smalland would minimize optical performance of the intraocular implant. Incertain embodiments, the wires can also themselves provide the movementof the mask thereby eliminating the use of external actuators. The wirescould include a shape memory alloy such as nitinol which, when heatedcan deform to cause movement of the mask. Nitinol wires can be, forexample, about 0.003 inches in diameter.

Diamagnetic levitation can also be used to position the mask. Adiamagnetic substance is one whose atoms have no permanent magneticdipole moment. When an external magnetic field is applied to adiamagnetic substance a weak magnetic dipole moment is induced in thedirection opposite the applied field. Pyrolytic graphite is stronglydiamagnetic, and pyrolytic graphite has a specific gravity around 2.1,so it is easily levitated. Diamagnetic levitation occurs by bringing adiamagnetic material in close proximity to material that produces amagnetic field. The diamagnetic material will repel the materialproducing the magnetic field. Most substances that are not magnetic areweakly diamagnetic. The repulsive force may not be strong enough toovercome the force of gravity. To cause diamagnetic levitation, both thediamagnetic material and magnetic material produce a combined repulsiveforce to overcome the force of gravity. The magnetic field can be from apermanent magnet or can be from an electromagnet. The mask 9202 can be adiamagnetic material that can be levitated with a magnetic field 9204,as illustrated in FIG. 42. The magnetic field can be manipulated toposition the mask within a mold cavity. For example, the magnetic fieldcan be configured to constrain the mask while also levitating it.Multiple magnetic field (e.g., magnets) can be used to control theproperties and shape of the magnetic field. FIGS. 43A and 43B illustratetop views of examples of first magnetic fields 9302, 9308 and secondmagnetic fields 9304, 9310 that can constrain a mask 9306, 9312. Thefirst magnetic fields 9302, 9308 have an opposite magnetic field as thesecond magnetic fields 9304, 9310. In certain embodiments, the maskincludes a permanent magnetic field. If the mask has a permanentmagnetic field, more force between the mask and the magnetic fields maybe able to be produced.

A mask may also be levitated by using sonic levitation. Acousticradiation pressure can produce intense sound wave in the liquid polymerto move the mask. Electrostatic levitation can also be used by applyingan electrostatic field to the mask to counterbalance gravity. Highvoltage electrodes 9402 can be oriented around the mask 9404, asillustrated in FIG. 44. For example, two electrodes 9402 can be orientedon opposite sides of the mask 9404 on each of three axes that areperpendicular to each other for a total of six electrodes. Theelectrodes can be in electrical communication with a high voltagegenerator and controller 9406.

The mask may be formed by a bistable display (e.g., Cholesteric LiquidCrystal Display (ChLCD)) that is capable of maintaining a state (e.g.,opaque or transparent) without electrical power. FIG. 45 illustrates abistable display 9502. Electrical power can be used to change the stateof a pixel 9504 to either opaque or transparent. The pixels that areopaque can form the mask. Therefore, the inner diameter, outer diameter,and aperture of the mask can be adjusted.

VII. Intraocular Implants with Haptics

Anterior chamber intraocular lens have generally been made frompolymethyl methacrylate (PMMA), which is a relatively hardthermoplastic. A certain amount of rigidity was believed necessary tomaintain stability of the implant in the anterior chamber. For example,a stiffening element can be added to the haptic to achieve the desirablestability of the intraocular lens (see, e.g., U.S. Pat. No. 6,228,115(Hoffmann, et al.)). However, the compressive forces of PMMA intraocularlenses is far in excess of what is required for stability. It is alsopossible to construct intraocular lenses from soft materials such assilicones, hydrogels and soft acrylics. With these softer materials,there is some question as to the stability of the implant in theanterior chamber; however, intraocular implants made from soft materialare stable when certain compressive forces and contact areas are used.

For example, the commercially available Bausch & Lomb NuVita Model MA 20exhibits a force response of approximately 2.7 mN at 1 mm of compressionwhen measured according to the industry standard compression test,ISO/DIS 11979-3. The intraocular implant illustrated in FIGS. 46-47 canexhibit a force response of less than approximately 0.5 mN at 1 mm ofcompression when made from a soft acrylic material, which is similar tothe commercially available Alcon Model SA30EL posterior chamber lens.The broad haptic contact areas found on posterior chamber IOLs such asthe Alcon Model SA30EL are generally not suitable for implantation inthe anterior chamber because such designs can cause translationalmovement of the haptic contact points relative to the anterior chambertissue, resulting in chronic irritation and the formation of synechia.The formation of calluses around the haptics may also cause late-onsetglaucoma. Advantageously, an intraocular implant having haptics thatcontact the anterior chamber angle at only four locations, and with aratio of haptic spread to optic diameter of less than 1.5, andpreferably around 1.3 for a 5.5 mm optic provides sufficient stabilitywithout excessive angle contact.

As illustrated in FIGS. 46 and 47, an intraocular implant 5010 caninclude an intraocular body 5014 with a mask 5020 in or on the implantbody 5014. The implant body 5014 can include a lens body. For example,the lens body can include any lens body described herein. In addition,the intraocular implant 5010 can be implanted in phakic or aphakicpatients.

In certain embodiments, the intraocular implant 5010 includes a mask5020 embedded in or carried by a single piece comprising a soft acrylic,such as those described in U.S. Pat. Nos. 5,290,892, 5,403,901,5,433,746, 5,674,960, 5,861,031 and 5,693,095, the disclosures of whichare hereby incorporated by reference in their entirety. Such a materialallows the intraocular implant 5010 to be rolled or folded so as to fitthrough a 3.5 mm or less surgical incision and implanted in the anteriorchamber of an eye. The intraocular implant 5010 may also be made from asoft silicone or hydrogel material. In certain embodiments, theintraocular implant 5010 includes two opposing pairs of footplates 5012joined to the implant body 5014 by haptics 5016 and ramps 5018. Theimplant body 5014 may have any suitable diameter, but is preferablybetween 5.0 mm and 6.0 mm. The footplates 5012 are separated by thehaptic 5016 by a distance S, that is preferably less than 1.5 times thediameter of implant body 5014, and most preferably around 1.3 times thediameter of implant body 5014. The footplates 5012 and haptics 5016preferably are between 0.20 and 0.30 mm thick, which provides sufficientcompressive force, while minimizing axial vaulting of intraocularimplant 5010 to less than 1.5 mm and preferably less than 1.0 mm whenthe footplates 5012 and haptics 5016 are compressed 1 mm. As discussedabove, the compressive force of the haptics 5016 and footplates 5012 canbe sufficient for the stability of intraocular implant 5010, but not solarge to cause irritation or pupil ovaling. Preferably, the intraocularimplant 5010 exhibits a force response of approximately less than 0.5mN, and more preferably, approximately less than 0.3 mN, when theintraocular implant 5010 is compressed 1 mm according to industrystandard test ISO/DIS 11979-3.

The mask 5020 has an aperture 5022 to improve the depth of focus of ahuman eye. In certain embodiments, the aperture 5022 is a pin-holeaperture. The mask 5020 can extend through the entire anterior-posteriordimension of the implant body 5014, as illustrated in FIG. 48A.Preferably, the mask will be no more than about 85% or 95% of theanterior-posterior thickness of the finished lens, so that the materialof the lens body will overlay and encapsulate the mask to provide acontinuous outer surface.

The implant of FIG. 46, and other implants described below can bemanufactured by lamination, or other techniques known in the art. Forexample, the mask may be placed into a mold cavity followed byintroduction of monomer, polymer or other lens precursor material whichis caused to change from a flowable state to a solid state toencapsulate the mask.

The mask 5021, 5023 can be positioned on, neighboring, near or adjacentthe anterior or posterior surface of the implant body 5011, 5013, asillustrated in FIGS. 48B and 48C, respectively. In certain embodiments,the mask is spaced apart from the surfaces of the implant body. Forexample, the mask 5025 can be positioned substantially at a centralportion 5024, e.g., midway between the posterior and anterior surfacesof the implant body 5015, as illustrated in FIG. 48D. In certainembodiments, the mask 5027 is positioned between the central portion5024 and the posterior surface of the implant body 5017, as illustratedin FIG. 48E. Certain embodiments include the mask 5027 being positionedmidway, one-third or two-thirds between the central portion 5024 and theposterior surface of the implant body 5017. In certain otherembodiments, the mask 5029 is positioned between the central portion5024 and the anterior surface of the implant body 5019, as illustratedin FIG. 48F. Certain embodiments include the mask 5029 being positionedmidway, one-third or two-thirds between the central portion 5024 and theanterior surface of the implant body 5019.

VIII. Intraocular Implants with Masks

Intraocular implants for improving the vision of a patient, such as byincreasing the depth of focus of an eye of a patient, can includedifferent types of structures. FIGS. 49A-C illustrate an embodiment ofintraocular implant 6000 with an implant body 6002. The implant body6002 can include a mask 6006, an aperture 6008 surrounded by the mask6006, and an outer hole region 6010 around the mask 6006. The outer holeregion 6010 can have an outer portion 6012 of the implant body 6002around it.

The intraocular implant 6000 may include one or more haptics 6004 toprevent the intraocular implant 6000 from moving or rotating within theeye. The haptics 6004 can be a variety of shapes and sizes depending onthe location the intraocular implant 6000 is implanted in the eye. Forexample, the haptics 6004 illustrated in FIGS. 49A-C and the haptics6104 illustrated in FIGS. 50A-C have different haptics. The haptics6004, 6104 illustrated FIGS. 49-50 are generally suited for sulcusfixated intraocular implants 6000, 6100; however the intraocularimplants 6000, 6100 can be interchanged with any variety of haptic (e.g.haptics described above), and can be implanted into any suitablelocation within the eye (e.g. anterior chamber and posterior chamber).

As illustrated in FIGS. 49A and 49B, the outer hole region 6010 includesfive outer holes 6014 that form an annulus around the aperture 6008. Theouter hole region 6010 can include one or more connection portions 6016.The connection portions 6016 can be between at least two of the outerholes 6015. The connection portion 6016 connects or links the mask 6006and the outer portion 6012 of the implant body 6002. In certainembodiments, the mask 6006, the connection portions 6016 and the outerportion 6012 are a single integrated piece. In certain embodiments, thesingle integrated piece also includes haptics 6004. The outer holes 6014can be formed into the single integrated piece by stamped, cutting,burning, etching, etc.

In certain embodiments, at least a portion of the implant body isopaque. As used herein the term “opaque” is intended to indicate atransmission of no more than about 2% of incident visible light. In oneembodiment, at least a portion of the implant body 6002 is configured tobe opaque to more than 99% of the light incident thereon. In certainembodiments, at least a portion of the mask 6006 is opaque. In certainother embodiments, at least a portion of the mask 6006 is configured totransmit between 2 and 5% of incident visible light. In certainembodiments, the mask 6006 transmits no more than 95% of incidentvisible light. In certain embodiments, the intraocular implant 6000 is asingle integrated opaque piece.

The size of the aperture 6008 may be any size that is effective toincrease the depth of focus of an eye of a patient suffering frompresbyopia. For example, the aperture 6008 can be circular. In oneembodiment, the aperture 6008 has a diameter of less than about 2 mm. Inanother embodiment, the diameter of the aperture is between about 1.6 mmand about 2.0 mm. In another embodiment, the aperture 6008 has adiameter of about 1.6 mm or less. In another embodiment, the diameter ofthe aperture is about 1.4 mm. In certain embodiments, the diameter ofthe aperture is between about 0.85 mm to about 2.2 mm. In furtherembodiments, the diameter of the aperture is between about 1.1 mm toabout 1.7 mm.

In certain embodiments, the outer hole region 6010 of intraocularimplant s 6000 can improve low light vision. As the pupil of the eyeenlarges, eventually light rays will enter and pass through the outerhole region 6010 of the intraocular implant 6000. If the pupil of theeye is large enough so that light rays pass through outer hole region6010 of the intraocular implant 6000, additional light rays will strikethe retina.

The outer hole region 6010 can be a variety of shapes and sizes. FIGS.51-54 illustrate various embodiments of intraocular implants. FIGS.51A-E illustrate intraocular implants similar to the intraocular implant6000 of FIGS. 49A-C except that the number of connection portions 6016that connect the mask 6006 with the outer portion 6012 of the implantbody 6002 and the number of outer holes 6014 vary. FIGS. 51A, 51B, 51C,51D and 51E illustrate intraocular implants 6200 a, 6200 b, 6200 c, 6200d, 6200 e with one connection portion 6216 a and one outer hole 6214 ain the outer hole region 6010 a, with two connection portions 6216 b andtwo outer holes 6214 b in the outer hole region 6010 b, with threeconnection portions 6216 c and three outer holes 6214 c in the outerhole region 6010 c, with four connection portions 6216 d and four outerholes 6214 d in the outer hole region 6010 d, and with six connectionportions 6216 e and six outer holes 6214 e in the outer hole region 6010e, respectively.

Intraocular implants 6000 can have any number of connection portions6016. Embodiments include intraocular implants with at least oneconnection portion, at least two connection portions, at least threeconnection portions, at least four connection portions, at least fiveconnection portions, at least six connection portions, less than tenconnection portions, less than six connection portions, between one andten connection portions.

Similarly, intraocular implants 6000 can have any number of outer holes6014. Embodiments include intraocular implants with at least one outerhole, with at least two outer holes, with at least three outer holes,with at least four outer holes, at least five outer holes, at least sixouter holes, less than ten outer holes, less than six outer regionholes, between one and ten outer region holes.

In certain embodiments, the cross-sectional area perpendicular to thelength of an outer hole of at least one outer hole is at least about 1mm². In certain embodiments, the cross-sectional area perpendicular tothe length of the outer holes of at least two outer holes is at leastabout 1 mm for each of the at least two outer holes. In certainembodiments, area on the implant body of the outer hole region is atleast about 5 mm² or at least about 10 mm².

The distance between the outer perimeter 6018 of the aperture 6008 (e.g.inner perimeter 6018 of the mask 6006) and outer perimeter 6020 of themask 6006 can also vary. For example, the distance between the outerperimeter 6018 of the aperture 6008 and outer perimeter 6020 of the mask6006 can be adjusted depending on the particular patient and thelocation within the eye that the intraocular implant 6000 is positioned.Embodiments include the distance between the outer perimeter 6018 of theaperture 6008 and outer perimeter 6020 of the mask 6006 to be about 1.1mm, between about 0.8 and about 1.4 mm, between about 0.4 and about 2.5mm, greater than zero, greater than about 0.4 mm, and greater than about0.8 mm.

In certain embodiments, the aperture 6008 and/or the outer hole region6010 includes an optical power and/or refractive properties. Forexample, the aperture 6008 and/or the outer hole region 6010 can includean optic and can have an optical power (e.g. positive or negativeoptical power). In certain embodiments, the aperture 6008 and/or theouter hole region 6010 can correct for refractive errors of an eye.

The distance between the inner perimeter 6020 of the outer hole region6010 (e.g. outer perimeter 6020 of the mask 6006) and the outerperimeter 6022 of the outer hole region 6010 can be a variety of sizes.Embodiments include the distance between the inner perimeter 6020 of theouter hole region 6010 and the outer perimeter 6022 of the outer holeregion 6010 to be about 0.85 mm, greater than about 0.7 mm, greater thanabout 0.4 mm, greater than zero, between about 0.6 and about 1.0 mm, andbetween about 0.2 and about 1.5 mm. FIG. 52 illustrates an embodiment ofan intraocular implant 6300 where the outer perimeter 6322 of the outerhole region 6310 extends to near the outer perimeter 6324 of the implantbody 6302. For example, the distance between the outer perimeter 6322 ofthe outer hole region 6310 and the outer perimeter 6324 of the implantbody 6302 can be less than 0.5 mm or less than 0.1 mm.

In certain embodiments, the outer hole region 6010 has a incidentvisible light transmission of at least 90% or at least 95%. In certainembodiments, the outer hole region 6010 area includes at least 90% or atleast 95% outer holes 6014. In certain embodiments, the outer holeregion 6010 area includes no more than 10% or no more than 5% connectionportions 6016.

The outer hole region 6010 can have irregular annular shapes. FIGS.53A-C illustrate examples of variations in annular shapes. Asillustrated in FIG. 53A, the outer hole region 6410 a has differentsized outer holes 6414 a. The distance between the inner perimeter 6420a of the outer hole region 6410 a and the outer perimeter 6422 a of theouter hole region 6410 a can vary annularly around the outer hole region6410 a. The distance between the outer perimeter 6422 a of the outerhole region 6410 a and the outer perimeter 6424 a of the implant body6402 a can also vary annularly around the outer hole region 6410 a.

In certain embodiments, connection portions 6016 extend substantiallyradially out from the center of the implant body 6002, as illustrated inFIG. 49B. FIG. 53B illustrates an embodiment where the connectionportions 6416 b do not extend radially out from the center of theimplant body 6402 b. For example, the lengths of the connection portions6416 b can be substantially parallel.

In certain embodiments, the outer hole region 6010 is substantiallyannularly circle-shaped, as illustrated in FIGS. 49-51. As illustratedin FIG. 53C, the outer hole region 6410 c can be substantially annularlysquare-shaped. In certain embodiments, the outer hole region 6410 c isannularly polygon-shaped.

In certain embodiments, the outer hole region 6010 can be asubstantially continuous annulus, as illustrated in FIGS. 49-53. Asillustrated in FIG. 54, the outer hole region 6500 can have a partialannular shape. In certain embodiments, the outer hole region 6010 atleast partially surrounds the mask 6506 and/or the aperture 6508.

In certain embodiments, the aperture 6008 is substantially centered inthe mask 6006, as illustrated in FIGS. 49-53. The aperture 6608, 6708can also be off-center in the mask 6606, 6706, as illustrated in FIGS.55 and 56. FIG. 55 illustrates an embodiment with the aperture 6608substantially centered in the implant body 6602 with the outer holeregion 6610 off-center in the implant body 6602 (e.g. the outer holeregion 6610 closer to one edge of the implant body 6602 than an oppositeedge of the implant body 6602). FIG. 56 illustrates an embodiment withthe outer hole region 6710 substantially centered in the implant body6702 with the aperture 6708 off-center within the outer hole region6710. The aperture 6008 can be substantially circular or any shape asdescribed above.

The intraocular implant 6000 can be a variety of thicknesses (e.g.distance between the posterior and anterior surfaces). For example, thethickness of the intraocular implant 6000 can be about 0.2 mm, less thanabout 0.5 mm, less than about 0.3 mm, or less than about 0.2 mm.

The outer holes 6014 can be open holes or can be filled with asubstantially transparent material. For example, the outer holes 6014can be formed in the implant body 6002, and a substantially transparentmaterial can used to fill the outer holes 6014.

The mask 6006 of the intraocular implant 6000 can be any of thevariations described above. In certain embodiments, the mask 6006includes light transmission holes. For example, the configuration of themask 4000 illustrated in FIG. 24A can be a configuration of a mask 6806used in an intraocular implant 6800, as illustrated in FIG. 57.

FIG. 58 illustrates another embodiment of an intraocular implant 6900with a mask region 6930 with light transmission holes 6932. In certainembodiments, the intraocular implant 6900 is opaque in at least oneregion. For example, the mask region 6930 can be opaque. The lighttransmission holes 6932 can vary in size, density (e.g., number of holesper unit area) and/or surface area (e.g., percentage of surface area oflight transmission holes 6932 compared to the total surface area of themask region 6930) in one or more portions of the mask region 6930. Forexample, the size, density and/or surface area of the light transmissionholes 6932 can increase or decrease radially from the inner periphery6918 of the mask region 6930 to the outer periphery 6924 of the implantbody 6902. The transition of the size and/or density of lighttransmission holes 6932 can be gradual or one or more steps. Asillustrated in the embodiment in FIG. 58, the size of the lighttransmission holes 6932 gradually increase in size radially out from theaperture 6908 while the number of light transmission holes per unit areadecreases. In certain embodiments, the light transmission holes 6932have irregular spacing or have an irregular pattern.

Various embodiments have been described above. Although the inventionhas been described with reference to these specific embodiments, thedescriptions are intended to be illustrative and are not intended to belimiting. Various modifications and applications may occur to thoseskilled in the art without departing from the true spirit and scope ofthe invention as defined in the appended claims.

1. A intraocular implant comprising: an implant body comprising a bodymaterial; a mask with an aperture positioned within the implant body,the mask comprises a plurality of holes that extend between a posteriorsurface and an anterior surface of the mask; and wherein the bodymaterial extends through the plurality of holes of the mask, and furtherwherein the plurality of holes are characterized in that at least one ofthe hole size, shape, orientation, and spacing of the plurality of holesis varied to reduce the tendency of the holes to produce visiblediffraction patterns.
 2. The intraocular implant of claim 1, wherein theplurality of holes are positioned at irregular locations.
 3. Theintraocular implant of claim 1, wherein a plurality of the holescomprise first hole size, shape or spacing and at least anotherplurality of holes comprise a second hole size, shape, or spacingdifferent from the first holes size, shape, or spacing.
 4. Theintraocular implant of claim 1, wherein a first plurality of the holescomprise first hole size, a second plurality of the holes comprise asecond hole size different form the third hole size, and a thirdplurality of holes comprise a third hole size different from the firstholes size and the second hole size.
 5. The intraocular implant of claim1, wherein the aperture comprises a diameter of from about 0.85 mm toabout 1.8 mm.
 6. The intraocular implant of claim 1, wherein the maskcomprises an outer diameter of from about 3 mm to about 5 mm.
 7. Theintraocular implant of claim 1, wherein the mask increases depth offocus of a patient.
 8. The intraocular device of claim 1, furthercomprising at least one haptic attached to the implant body to supportthe intraocular device after being implanted within an eye.